All Questions (Site-wide)

Boots GDP Training: 28/08

Quiz: GDP Training Pre-Test: Boots

Q1: What does GDP stand for?

• {good distribution practice}

Q2: What guideline of the International Conference of Harmonisation (ICH) covers Quality Risk Management?

✓ Q9

• Q4-Q4B

• Q13

• Q11

Q3: For how long do GDP records need to be kept?

• At least 7 years

✓ At least 5 years

• At least 3 years

• Forever

Q4: How could you segregate stock in the warehouse to reduce the risk of picking errors? Choose three

✓ Put them in separate bins or locations

✓ Store similar products separately

• Mark each box with a pen and store in alphabetical order as per the product or brand

✓ Ensure that segregation is clear on all computer systems

Q5: Which six are responsibilities of an RP as per the EU Guidance 2013/C 343/01?

✓ Ensuring the QMS is implemented and maintained

✓ Keeping appropriate records of delegated duties

• Approving all new members of staff

✓ Carrying out self-inspections

✓ Ensuring initial and continuous training is given to all personnel

✓ Ensuring that customer complaints are dealt with effectively

✓ Approving returns to saleable stock

✓ Approving subcontracted activities

Q6: When should staff receive GDP training?

• After successful completion of their probationary period and then continuously

• Within their first few days and then continuously

✓ Before commencing any tasks and then continuously

• Anytime within their first few weeks and then continuously

Q7: Choose two occasions where staff should be re-trained.

✓ After errors have occurred

• Just before an inspection

• When personnel leave

✓ If there is a change to their job description and duties

Q8: In the event of a temperature excursion/deviation in your storage area, what should you do? Select four

• Wait until the quality meeting to raise the issue

✓ Inform the RP

✓ Document a deviation

✓ Record/estimate the length of the excursion,

• Tell the MHRA Defective Medicines Report Centre

✓ Take remedial actions to resolve the excursion

• Write a Yellow Card report

Q9: Receiving and dispatch bays should offer protection from what?

✓ Prevailing weather conditions

• Contamination

• Pests

• Mix-ups/confusions

Q10: What four things should specifically be prohibited in the storage areas of wholesalers?

• Hygiene Products

✓ Food

✓ Smoking materials

• Mobile Phones

✓ Drink

• Personal Bags/Belongings

✓ Personal Medication

Q11: Choose four important things you should check when receiving a delivery.

• That the delivery vehicle will ensure easy transfer of the products

✓ The address on the delivery

✓ That all packages are present

✓ The driver’s ID

✓ The data logger to see whether there were any excursions

• The driver’s licence

Q12: What does SOP stand for?

• {}

Q13: What is the acceptable temperature range (in Celsius) for cold chain products?

• 0-8

• 2-10

• 0-6

✓ 2-8

Q14: How many suitable reference points should your thermometer/logger/ system be calibrated to?

• 5

✓ 3

• 6

• 2

Q15: Which 4 letter principle relating to product expiry dates should goods be stored under
– what does it mean?

✓ FEFO
– First Expiry, First Out

• FIFO
– First In, First Out

Q16: How do you qualify a UK pharmacy?

• Through the MHRA

✓ Through the GPhC

• Through the DMRC

Q17: Choose three ways you can approve/bona fide an EU wholesale supplier.

• Care and Quality Commission

• MHRA DMRC

✓ EUDRA GMDP

✓ Post-inspection close-out letter

• GPhC

✓ GDP Certificate

Q18: How can a product be considered falsified? Choose three.

✓ Its History

• Its Ingredients

✓ Its Identity

• Incorrect printing

• Its Packaging

✓ Its Source

Q19: What do the letters CAPA stand for?

• Correct, Accurate, Positive, Attributable

✓ Corrective Action, Preventive Action

• Current Action, Past Action

• Correction Activity, Prevention Activity

Q20: Select the correct definition for ‘Correction’ and ‘Corrective Action’.

✓ Correction:

Remove the nonconformity to make the product/service acceptable for use.

• Corrective Action:

Remove the nonconformity to make the product/service acceptable for use.

• Correction:

Correct the root cause of the problem so it doesn't occur again.

✓ Corrective Action:

Correct the root cause of the problem so it doesn't occur again.

Q21: Who can recommend a change to the QMS?

✓ All Personnel

• Only the RP

• The RP and Licence Holder

• Senior Management

Q22: What are the two main reasons why goods must be stored off the floor?

✓ Risk of contamination

• Risk of them being moved out of the way resulting in mix-ups

✓ To reduce the risk of temperature excursion

• To ensure they are not forgotten about during picking, reducing waste

Q23: What does WDA stand for?

• {}

Q24: What is the name of the MHRA website for reporting fake/faulty medicines and devices, and adverse reactions?

• MHRA Red Card

• MHRA Report Centre

• MHRA DMRC

✓ MHRA Yellow Card

Q25: How long do you have to complete a Class 2 recall?

• 24 hours

• 36 hours

✓ 48 hours

• 72 hours

Q26: What are the 2 classifications of complaint in GDP?

• Personnel/Customer Service

• Packaging

✓ Product Quality

✓ Service/Distribution

• Major

• Minor

Q27: Who must be the final arbitrator of complaints in GDP?

✓ The RP

• Senior Management

• The head of customer service

• The head of the department of which the complaint is about

Q28: What is the MHRA DMRC?

• Where destruction of medicines are reported

✓ Where defective medicines are reported.

• Where distribution of medicines is registered

• Where drivers register to be able to transport medicinal products

Q29: What is the purpose of a self-inspection, as per Chapter 8 of the EU Guidance 2013/C 343/01?

• To detect problems before they escalate

✓ To measure compliance and suggest improvements

• To assess and evaluate the performance of all personnel

• To see what can be added to the company to increase profits/business

Q30: What is the maximum time that a transit point can hold goods without having their own WDA? Select 1 answer for ambient and 1 for chilled

• Ambient:

24 hours

✓ Ambient:

36 hours

• Ambient:

48 hours

✓ Chilled:

0 hours

• Chilled:

6 hours

• Chilled:

12 hours

Q31: When organising transport without temperature control, what should be in place ahead of shipping product?

• Curtain sided vehicle to permit airflow

• Temperature mapping of the uncontrolled vehicle

✓ A transport risk assessment

Q32: Can a licensed broker procure and supply medicines?

• Yes

✓ No

Q33: What does QMS stand for?

• {quality management system}

Q34: What does MHRA stand for?

• {}

Q35: What does RP stand for?

• {responsible person}

Q36: Who is responsible for the quality system, as stated in the EU Guidance?

• RP

• Licence Holder

✓ Senior Management

• All Personnel

Q37: Choose four things that should be covered in a management review.

✓ Anything that may enhance the quality system

• A review of the RP's performance

✓ Measurement of the achievements of the quality systems objectives

✓ Any changes to business objectives and environment

✓ Assessment of performance indicators

Q38: Why is there a requirement for adequate separation between receipt, dispatch and storage areas?

• To help maintain hygiene standards in these areas

✓ To prevent cross contamination of products and picking errors

• To reduce the risk of theft and/or damage to the products

• To help with maintaining the correct conditions for products, e.g. temperature

Q39: Choose two circumstances where you should re-map a warehouse.

✓ If the racking configuration is significantly changed

✓ If new heating/cooling equipment is added

• If more staff are employed

• If there is a temperature excursion

Quiz: GDP Training Post Test: Boots

Q1: In the event of a temperature excursion/deviation in your fridge, what should you do? Select four

• Wait until the quality meeting to raise the issue

✓ Inform the RP

✓ Document a deviation

✓ Record/estimate the length of the excursion

• Tell the MHRA Defective Medicines Report Centre

✓ Take remedial actions to resolve the excursion

• Write a Yellow Card report

Q2: What are the 2 classifications of complaint in GDP?

• Personnel/Customer Service

• Packaging

✓ Product Quality

✓ Service/Distribution

• Major

• Minor

Q3: What does GDP stand for?

• {good distribution practice}

Q4: Receiving and dispatch bays should offer protection from what?

✓ Prevailing weather conditions

• Contamination

• Pests

• Mix-ups/confusions

Q5: Who must be the final arbitrator of complaints in GDP?

✓ The RP

• Senior Management

• The head of customer service

• The head of the department of which the complaint is about

Q6: What does SOP stand for?

• {}

Q7: What four things should specifically be prohibited in the storage areas of wholesalers?

• Hygiene Products

✓ Food

✓ Smoking materials

• Mobile Phones

✓ Drink

• Personal Bags/Belongings

✓ Personal Medication

Q8: What is the MHRA DMRC?

• Where destruction of medicines are reported

✓ Where defective medicines are reported

• Where distribution of medicines is registered

• Where drivers register to be able to transport medicinal products

Q9: What does WDA stand for?

• {}

Q10: Choose four important things you should check when receiving a delivery.

• That the delivery vehicle will ensure easy transfer of the products

✓ The address on the delivery

✓ That all packages are present

✓ The driver’s ID

✓ The data logger to see whether there were any excursions

• The driver’s licence

Q11: What are the two main reasons why goods must be stored off the floor?

✓ Risk of contamination

• Risk of them being moved out of the way resulting in mix-ups

✓ To reduce the risk of temperature excursion

• To ensure they are not forgotten about during picking, reducing waste

Q12: What does QMS stand for?

• {quality management system}

Q13: What is the purpose of a self-inspection, as per Chapter 8 of the EU Guidance 2013/C 343/01?

• To detect problems before they escalate

✓ To measure compliance and suggest improvements

• To assess and evaluate the performance of all personnel

• To see what can be added to the company to increase profits/business

Q14: What does MHRA stand for?

• {}

Q15: What is the acceptable temperature range (in Celsius) for cold chain products?

• 0-8

• 2-10

• 0-6

✓ 2-8

Q16: What is the maximum time that a transit point can hold goods without having their own WDA? Select 1 answer for ambient and 1 for chilled

• Ambient:

24 hours

✓ Ambient:

36 hours

• Ambient:

48 hours

✓ Chilled:

0 hours

• Chilled:

6 hours

• Chilled:

12 hours

Q17: What does RP stand for?

• {responsible person}

Q18: How many suitable reference points should your thermometer/logger/ system be calibrated to?

• 5

✓ 3

• 6

• 2

Q19: When organising transport without temperature control, what should be in place ahead of shipping product?

• Curtain-sided vehicle to permit airflow

• Temperature mapping of the uncontrolled vehicle

✓ A transport risk assessment

Q20: Who is responsible for the quality system, as stated in the EU Guidance?

• The RP

✓ Senior Management

• Licence Holder

• All Personnel

Q21: Which 4 letter principle relating to product expiry dates should goods be stored under
– what does it mean?

✓ FEFO
– First Expiry, First Out

• FIFO
– First In, First Out

Q22: Can a licensed broker procure and supply medicines?

• Yes

✓ No

Q23: Choose four things that should be covered in a management review.

✓ Anything that may enhance the quality system

• A review of the RP's performance

✓ Measurement of the achievements of the quality systems objectives

✓ Any changes to business objectives and environment

✓ Assessment of performance indicators

Q24: How do you qualify a UK pharmacy?

• Through the MHRA

✓ Through the GPhC

• Through the DMRC

Q25: What guideline of the International Conference of Harmonisation (ICH) covers Quality Risk Management?

✓ Q9

• Q4-Q4B

• Q13

• Q11

Q26: Choose three ways you can approve/bona fide an EU wholesale supplier.

• Care and Quality Commission

• MHRA DMRC

✓ EUDRA GMDP

✓ Post-inspection close-out letter

• GPhC

✓ GDP Certificate

Q27: Why is there a requirement for adequate separation between receipt, dispatch and storage areas?

• To help maintain hygiene standards in these areas

✓ To prevent cross contamination of products and picking errors

• To reduce the risk of theft and/or damage to the products

• To help with maintaining the correct conditions for products, e.g. temperature

Q28: How can a product be considered falsified? Choose three.

✓ Its History

• Its Ingredients

✓ Its Identity

• Incorrect printing

• Its Packaging

✓ Its Source

Q29: For how long do GDP records need to be kept?

• At least 7 years

✓ At least 5 years

• At least 3 years

• Forever

Q30: What do the letters CAPA stand for?

• Correct, Accurate, Positive, Attributable

✓ Corrective Action, Preventive Action

• Current Action, Past Action

• Correction Activity, Prevention Activity

Q31: How could you segregate stock in the warehouse to reduce the risk of picking errors? Choose three

✓ Put them in separate bins or locations

✓ Store similar products separately

• Mark each box with a pen and store in alphabetical order as per the product or brand

✓ Ensure that segregation is clear on all computer systems

Q32: Select the correct definition for ‘Correction’ and ‘Corrective Action’.

✓ Correction:

Remove the nonconformity to make the product/service acceptable for use.

• Corrective Action:

Remove the nonconformity to make the product/service acceptable for use.

• Correction:

Correct the root cause of the problem so it doesn't occur again.

✓ Corrective Action:

Correct the root cause of the problem so it doesn't occur again.

Q33: Which six are responsibilities of an RP as per the EU Guidance 2013/C 343/01?

✓ Ensuring the QMS is implemented and maintained

✓ Keeping appropriate records of delegated duties

• Approving all new members of staff

✓ Carrying out self-inspections

✓ Ensuring initial and continuous training is given to all personnel

✓ Ensuring that customer complaints are dealt with effectively

✓ Approving returns to saleable stock

✓ Approving subcontracted activities

Q34: Who can recommend a change to the QMS?

✓ All Personnel

• Only the RP

• The RP and Licence Holder

• Senior Management

Q35: When should staff receive GDP training?

• After successful completion of their probationary period and then continuously

• Within their first few days and then continuously

✓ Before commencing any tasks and then continuously

• Anytime within their first few weeks and then continuously

Q36: What is the name of the MHRA website for reporting fake/faulty medicines and devices, and adverse reactions?

• MHRA Red Card

• MHRA Report Centre

• MHRA DMRC

✓ MHRA Yellow Card

Q37: Choose two occasions where staff should be re-trained.

✓ After errors have occurred

• Just before an inspection

• When personnel leave

✓ If there is a change to their job description and duties

Q38: How long do you have to complete a Class 2 recall?

• 24 hours

• 36 hours

✓ 48 hours

• 72 hours

Q39: Choose two circumstances where you should re-map a warehouse.

✓ If the racking configuration is significantly changed

✓ If new heating/cooling equipment is added

• If more staff are employed

• If there is a temperature excursion

Protected: Corrective Action Preventive Action

Quiz: Corrective Action Preventive Action (CAPA) Post Test

Q1: What is a Corrective Action?

• An action taken to eliminate the root cause, or most probable root cause, of a detected non-conformity or other undesirable situation.

• An immediate remedial action taken to address or contain a detected risk or safety issue, but does not address the cause of the issue i.e., terminating a process.

• An action taken to eliminate the cause of a potential non-conformity or other undesirable potential situation.

• An action to assess the suitability of corrective actions taken to prevent recurrence of the non-conformity.

Q2: What Is A Preventive Action?

• An action taken to eliminate the root cause, or most probable root cause, of a detected non-conformity or other undesirable situation.

• An immediate remedial action taken to address or contain a detected risk or safety issue, but does not address the cause of the issue i.e., terminating a process.

• An action taken to eliminate the cause of a potential non-conformity or other undesirable potential situation.

• An action to assess the suitability of corrective actions taken to prevent recurrence of the non-conformity.

Q3: What Is Correction / Containment Action?

• An action taken to eliminate the root cause, or most probable root cause, of a detected non-conformity or other undesirable situation.

• An immediate remedial action taken to address or contain a detected risk or safety issue, but does not address the cause of the issue i.e., terminating a process.

• An action taken to eliminate the cause of a potential non-conformity or other undesirable potential situation.

• An action to assess the suitability of corrective actions taken to prevent recurrence of the non-conformity.

Q4: CAPA systems drive several key components in a QMS. Tick all that apply.

• Continuous improvement.

• Prevention of occurrence of product and/or quality problems.

• Prevention of recurrence of product and/or quality problems.

• Enhanced understanding of those processes and/or products to which it is applied.

• The assessment of the effectiveness of actions.

• Determines root cause.

Q5: Select all the potential sources of CAPAs from the list below.

• Deviations.

• Complaints.

• Recalls.

• Product Rejections.

• Self Inspections.

• QMS Review.

• Regulatory Audits.

Q6: Name a Root Cause analysis tool.

• Five Why's

• Fishbone / Ishikawa

• FMEA

Q7: Classify the below statement as 'Minor', 'Major', or a 'Critical' CAPA risk.

• Critical

• Minor

• Major

Q8: What is the "SMART" acronym in relation to CAPAs?

(No discrete answer options found; likely essay or cloze type)

Q9: What are the "Five W's?"

(No discrete answer options found; likely essay or cloze type)

Q10: What is the definition of an Effectiveness Check?

(No discrete answer options found; likely essay or cloze type)

Q11: When should an Effectiveness Check be designed?

(No discrete answer options found; likely essay or cloze type)

Q12: "An Effectiveness Check is the verification that the defined CAPA actions have been successfully implemented."

(No discrete answer options found; likely essay or cloze type)

Q13: Which of the following are verification methods for Effectiveness Checks? (select all that apply)

(No discrete answer options found; likely essay or cloze type)

Q14: What are some benefits of having a CAPA system? (Select all that apply)

(No discrete answer options found; likely essay or cloze type)

Data Integrity

Quiz: Pre-Test: Data Integrity

Q1: What does the first A stand for in the ALCOA principle?

• A{}

Q2: What does the L stand for in the ALCOA principle?

• L{}

Q3: What does the C stand for in the ALCOA principle?

• C{}

Q4: What does the O stand for in the ALCOA principle?

• O{}

Q5: What does the final A stand for in the ALCOA principle?

• A{}

Q6: Which statement best describes Attributable?

• Data being recorded at the time of action.

• The record reflects what actually happened.

✓ Who did the action being recorded?

• The information is readable and permanent (cannot be deleted).

• The record is stored or a true copy of the record is kept.

Q7: Which statement best describes Legible?

• Data being recorded at the time of action.

• The record reflects what actually happened.

• Who did the action being recorded?

✓ The information is readable and permanent (cannot be deleted).

• The record is stored or a true copy of the record is kept.

Q8: Which statement best describes Contemporaneous?

✓ Data being recorded at the time of action.

• The record reflects what actually happened.

• Who did the action being recorded?

• The information is readable and permanent (cannot be deleted).

• The record is stored or a true copy of the record is kept.

Q9: Which statement best describes Original?

• Data being recorded at the time of action.

• The record reflects what actually happened.

• Who did the action being recorded?

• The information is readable and permanent (cannot be deleted).

✓ The record is stored or a true copy of the record is kept.

Q10: Which statement best describes Accurate?

• Data being recorded at the time of action.

✓ The record reflects what actually happened.

• Who did the action being recorded?

• The information is readable and permanent (cannot be deleted).

• The record is stored or a true copy of the record is kept.

Q11: One of your colleagues completed some work today but forgot to sign the log book before he left work to go home. Is it ok for you to sign his name as you know that the work was completed by him?

• Yes

✓ No

Q12: Does using a single-sign on with the same password comply with Data Integrity principles?

• Yes

✓ No

Q13: Which statement below best describes Data Integrity regarding documents, records and data?

• They are never changed or altered under any circumstance.

• Stored in a password protected storage room.

• Can only be accessed by senior management.

✓ Remain secure and unaltered until their expiry date.

Quiz: Data Integrity Post-Test

Q1: What does the first A stand for in the ALCOA principle?

• A{}

Q2: What does the L stand for in the ALCOA principle?

• L{}

Q3: What does the C stand for in the ALCOA principle?

• C{}

Q4: What does the O stand for in the ALCOA principle?

• O{}

Q5: What does the final A stand for in the ALCOA principle?

• A{}

Q6: Which statement best describes Attributable?

• Data being recorded at the time of action.

• The record reflects what actually happened.

✓ Who did the action being recorded?

• The information is readable and permanent (cannot be deleted).

• The record is stored or a true copy of the record is kept.

Q7: Which statement best describes Legible?

• Data being recorded at the time of action.

• The record reflects what actually happened.

• Who did the action being recorded?

✓ The information is readable and permanent (cannot be deleted).

• The record is stored or a true copy of the record is kept.

Q8: Which statement best describes Contemporaneous?

✓ Data being recorded at the time of action.

• The record reflects what actually happened.

• Who did the action being recorded?

• The information is readable and permanent (cannot be deleted).

• The record is stored or a true copy of the record is kept.

Q9: Which statement best describes Original?

• Data being recorded at the time of action.

• The record reflects what actually happened.

• Who did the action being recorded?

• The information is readable and permanent (cannot be deleted).

✓ The record is stored or a true copy of the record is kept.

Q10: Which statement best describes Accurate?

• Data being recorded at the time of action.

✓ The record reflects what actually happened.

• Who did the action being recorded?

• The information is readable and permanent (cannot be deleted).

• The record is stored or a true copy of the record is kept.

• Yes

✓ No

Q12: Does using a single-sign on with the same password comply with Data Integrity principles?

• Yes

✓ No

Q13: Which statement below best describes Data Integrity regarding documents, records and data?

• They are never changed or altered under any circumstance.

• Stored in a password protected storage room.

✓ Remain secure and unaltered until their expiry date.

• Can only be accessed by senior management.

Driver Training

Quiz: DRIVER TRAINING: PRE-TEST

Q1: “Sufficient equipment and consumables should be in place for the standard operation of the vehicle.” Select three that apply.

✓ Webbing / Strapping

✓ Pallet Wrap / Film

• String/rope

• Bungee cords

✓ Cleaning Material (non-taint)

✓ Foam/cardboard corner strips

Q2: Find the incorrect statement:

“The driver must promptly …”

• Report faults that might adversely affect the operation of the vehicle.

✓ Report faults that might mean he can’t change the radio station.

• Report faults that might pose a risk to human life.

• Report faults that might pose a risk to the pharmaceutical products.

Q3: For how long should vehicular temperature mapping records be kept?

• 2 years

• Forever

✓ 5 years

• 12 months

Q4: You have 8 temperature controlled vehicles that are exactly identical in type and age. What should be in place if you feel that you only need to temperature-map 3 of them?

• A camera

✓ Risk Assessment

• Honest Drivers

Q5: Select 3 things that loading areas must be clear of.

• Moving Gear (e.g., pallet trucks)

✓ Rubbish (spent strapping etc)

✓ Stray or loose cables overhead or on the floor

✓ Traffic / awkwardly parked vehicles

Q6: “Payloads, pallets, cartons and containers should be _____ and _____ so that they do not slide around. _____ may help with stability.” Drag the answers in the correct descending order.

• arranged

• secured

• racking

Q7: During loading and unloading, what must a vehicle be?

• left running

✓ stable

• nice and warm

Q8: A vehicle must never be…

• old

✓ overloaded

• driven at night

Q9: Before loading, what part of the vehicle needs to be checked for potential hazards and/or obstruction?

✓ load deck

• Driver attire including footwear

✓ doors

✓ poorly secured payloads (already loaded)

Q10: What must be used to secure loads?

• pieces of wood

✓ strapping

• string

• bungee rope

Q11: Excessive pallet height / stacking is considered to be:

• a fire hazard

✓ a potential risk

• a nuisance

• hard to move

Q12: Vans must be alarmed, immobilised, and tracked:

• during work hours

• weekends only

• outside working hours

✓ 24/7

Q13: When the driver is not in possession of his key, the key should be kept where?

• In the manager’s desk drawer

• in a works locker

✓ in a key safe

• on a magnet

• In a place only the driver knows

Q14: “Drivers have the liberty to occasionally give lifts to people who otherwise are not working for the company.” Is this a correct statement?

• yes

✓ no

Q15: “It is sufficient for Controlled Drugs (CDs) to be hidden out of sight in the van.” True or False?

• true

✓ false

Q16: Cold Chain goods:

Where should you NEVER place a cold chain box containing chilled pharma products?

Q17: If a site does not hold a WDA licence, it cannot hold ambient temperature products for more than:

• 24 hours

• 72 hours

✓ 36 hours

• 5 days

Q18: “A driver will have a paper or electronic despatch record which must be signed by the customer upon receipt of their goods.”

✓ true

• false

Q19: When does the driver assume full responsibility for the products?

• When the Purchase Order has been raised

✓ Once the driver and vehicle leaves the warehouse with the products

• When the products are being taken and loaded into the van

Q20: If there is a discrepancy with the delivery, when can a driver leave the receiving premises?

• With the client’s permission

• With the management’s permission

✓ When the discrepancy has been resolved

• When his schedule says he has to leave.

Q21: What items must never be stored in the same area as pharmaceutical goods?

✓ smoking materials

✓ food

✓ drinks

✓ personal medication

Q22: A warehouse operative suggests placing a carton of medicines on the floor of the driver’s cab. Should you do this?

• Yes

✓ No

• Only if a manager says it's ok

Q23: A driver must perform a physical check of the vehicle before loading and leaving the premises. How often should this happen?

• Only after the vehicle has had a long journey

• Once a week

✓ Every day

• Once a month

Q24: A vehicle used in GDP is considered to be an extension of…what?

• My home

• The office

✓ The Warehouse

• My work environment

Q25: What is the ultimate goal of GDP Compliance?

• company profits

• Job Security

✓ Patient safety

• Management Satisfaction

Q26: What does "WDA" stand for?

• World Distributing Authority

• Wholesaling Distance Authorisation

✓ Wholesale Distribution Authorisation

Q27: “The wholesale operation can occasionally function without an RP.”

• True

✓ False

Q28: Choose 7 items that may appear on a regular vehicle checklist:

✓ tyres

✓ Lights (headlamps etc)

✓ Brakes

• Food/Drink in Glove Compartment

✓ Wipers

✓ Mirrors

• Vehicle Livery

✓ Windscreen

✓ Fuel and coolant levels

Q29: Cold Chain Boxes are also known as "passive cold boxes". What is the required temperature to be maintained within the box during transportation?

• -3 to +3 degC

• 0 to +5 degC

✓ +2 to +8 degC

• +8 to +15 degC

Quiz: Driver Training – Post Test

Q1: Choose 7 items that may appear on a regular vehicle checklist:

✓ tyres

✓ Lights (headlamps etc)

✓ Brakes

• Food/Drink in Glove Compartment

✓ Wipers

✓ Mirrors

• Vehicle Livery

✓ Windscreen

✓ Fuel and coolant levels

Q2: “Sufficient equipment and consumables should be in place for the standard operation of the vehicle.” Select three that apply.

✓ Webbing / Strapping

✓ Pallet Wrap / Film

• String/rope

• Bungee cords

✓ Cleaning Material (non-taint)

✓ Foam/cardboard corner strips

Q3: Find the incorrect statement:

“The driver must promptly …”

• Report faults that might adversely affect the operation of the vehicle.

✓ Report faults that might mean he can’t change the radio station.

• Report faults that might pose a risk to human life.

• Report faults that might pose a risk to the pharmaceutical products.

Q4: For how long should vehicular temperature mapping records be kept?

• 2 years

• Forever

✓ 5 years

• 12 months

Q5: You have 8 temperature controlled vehicles that are exactly identical in type and age. What should be in place if you feel that you only need to temperature-map 3 of them?

• A camera

✓ Risk Assessment

• Honest Drivers

Q6: Select 3 things that loading areas must be clear of.

• Moving Gear (e.g., pallet trucks)

✓ Rubbish (spent strapping etc)

✓ Stray or loose cables overhead or on the floor

✓ Traffic / awkwardly parked vehicles

Q7: “Payloads, pallets, cartons and containers should be _____ and _____ so that they do not slide around. _____ may help with stability.” Drag the answers in the correct descending order.

• arranged

• secured

• racking

Q8: During loading and unloading, what must a vehicle be?

• left running

✓ stable

• nice and warm

Q9: A vehicle must never be…

• old

✓ overloaded

• driven at night

Q10: Before loading, what part of the vehicle needs to be checked for potential hazards and/or obstruction?

✓ load deck

• Driver attire including footwear

✓ doors

✓ poorly secured payloads (already loaded)

Q11: What must be used to secure loads?

• pieces of wood

✓ strapping

• string

• bungee rope

Q12: Excessive pallet height / stacking is considered to be:

• a fire hazard

✓ a potential risk

• a nuisance

• hard to move

Q13: Vans must be alarmed, immobilised, and tracked:

• during work hours

• weekends only

• outside working hours

✓ 24/7

Q14: “Drivers have the liberty to occasionally give lifts to people who otherwise are not working for the company.” Is this a correct statement?

• yes

✓ no

Q15: When the driver is not in possession of his key, the key should be kept where?

• In the manager’s desk drawer

• in a works locker

✓ in a key safe

• on a magnet

• In a place only the driver knows

Q16: “It is sufficient for Controlled Drugs (CDs) to be hidden out of sight in the van.” True or False?

• true

✓ false

Q17: Cold Chain goods:

Where should you NEVER place a cold chain box containing chilled pharma products?

Q18: If a site does not hold a WDA licence, it cannot hold ambient temperature products for more than:

• 24 hours

• 72 hours

✓ 36 hours

• 5 days

Q19: “A driver will have a paper or electronic despatch record which must be signed by the customer upon receipt of their goods.”

✓ true

• false

Q20: When does the driver assume full responsibility for the products?

• When the Purchase Order has been raised

✓ Once the driver and vehicle leaves the warehouse with the products

• When the products are being taken and loaded into the van

Q21: If there is a discrepancy with the delivery, when can a driver leave the receiving premises?

• With the client’s permission

• With the management’s permission

✓ When the discrepancy has been resolved

• When his schedule says he has to leave.

Q22: What items must never be stored in the same area as pharmaceutical goods?

✓ smoking materials

✓ food

✓ drinks

✓ personal medication

Q23: A warehouse operative suggests placing a carton of medicines on the floor of the driver’s cab. Should you do this?

• Yes

✓ No

• Only if a manager says it's ok

Q24: A driver must perform a physical check of the vehicle before loading and leaving the premises. How often should this happen?

• Only after the vehicle has had a long journey

• Once a week

✓ Every day

• Once a month

Q25: A vehicle used in GDP is considered to be an extension of…what?

• My home

• The office

✓ The Warehouse

• My work environment

Q26: What is the ultimate goal of GDP Compliance?

• company profits

• Job Security

✓ Patient safety

• Management Satisfaction

Q27: What does "WDA" stand for?

• World Distributing Authority

• Wholesaling Distance Authorisation

✓ Wholesale Distribution Authorisation

Q28: “The wholesale operation can occasionally function without an RP.”

• True

✓ False

Q29: Cold Chain Boxes are also known as "passive cold boxes". What is the required temperature to be maintained within the box during transportation?

• -3 to +3 degC

• 0 to +5 degC

✓ +2 to +8 degC

• +8 to +15 degC

Falsified Medicines

Quiz: Falsified Medicines: Pre-Test

Q1: The definition of 'falsified medicine' was introduced in order to differentiate it from other illegal products knows as '_____________ medicines.'

• Forged

✓ Counterfeit

• Imitation

Q2: Which organisation co-ordinates Operation Pangea?

• Scotland Yard

• Federal Bureau of Investigation

✓ Interpol

Q3: What do the abbreviations 'EMVS' and 'NMVS' stand for in the FMD?

• European Marketing Verification System

✓ European Medicines Verification System

✓ National Medicines Verification System

• National Marketing Verification System

Q4: Under the FMD, all new packs of prescription medicines put on the market from 9th February 2019 have to have two safety features:

a UI and an ATD. What do these abbreviations mean?

• Unique Instruction

✓ Unique Identifier

• Anti-Tinkering Device

✓ Anti-Tampering Device

Q5: Which article in The Delegated Regulation (EU) 2016/161 states which structure the repositories system should adopt?

✓ Article 32

• Article 33

• Article 34

• Article 35

Q6: Linkage of batch data within the European Hub is required for what reason?

• The ability to run multiple verification queries of the database.

• The decommissioning of the pharmaceutical product at any point in the legal supply chain.

✓ For when relabelling or repackaging occurs.

Q7: The EMVO is responsible for the setting up and running of the European Hub. It is devised, funded and run by stakeholders of the pharmaceutical industry which include which of the below:

✓ Original Pack Manufacturers

• Dentists

✓ Parallel Distributors

✓ Wholesalers

• Opticians

✓ Hospitals and Hospital Pharmacists

• Schools

✓ Pharmacists

Q8: Which of the following are the responsibilities of the National Competent Authority with regards to the FMD?

• To supervise the functioning of the European Hub and inspect if required.

✓ To share reports with the EMVO.

✓ To contribute to the management of the national repository.

✓ To ensure compliance with the FMD as part of their routine inspections.

Q9: Each time the 2D barcode is scanned through the supply chain and the NMVS confirms the status of the product, this is called:

• Substantiation

✓ Verification

• Confirmation

• Corroboration

Q10: Which of the following use 'aggregated codes' when decommissioning pharmaceutical products?

• Wholesaler

✓ Pharmacy

Q11: Wholesalers in the UK are required to verify the safety features and decommission the UI of a medicinal product before they supply it to which of the following persons or institutions who are entitled to use, administer or supply medicines to the public (as part of their normal work) but who do not have access to the NMVS:

✓ Opticians

✓ Prisons

• Pharmacists

✓ Schools

• Other Wholesalers

✓ Dentists

Q12: Complete the following statement:

"Manufacturers, wholesalers and people who are authorised/entitled to supply medicinal products to the public can only return a decommissioned UI to an active status within __ days of original decommissioning."

• 8

✓ 10

• 12

• 14

Q13: Who must immediately be informed of medicinal products identified as falsified or suspected of being falsified?

✓ National Competent Authority

• European Medicines Agency

• Heads of Medicines Agency

✓ Marketing Authorisation Holder

Q14: The EMVO stakeholders consider that National Competent Authorities can only declare an end of the 'stabilisation periods' if the number of 'false' alerts is significantly decreased to below what level?

✓ 0.05%

• 1.0%

• 2.0%

Q15: To comply with the requirements of the Falsified Medicines Directive distance sellers of medicines must do what?

✓ Provide the contact details of the body with which the service is registered

✓ Display the common EU logo, that has been adopted for sites that sell medicines at a distance.

• Sell only general sale list medicines.

✓ Display a hyperlink to the national website of the Member State in which that business is established.

Q16: There are three terms that are used to describe the process through which an alert is triggered. What are these?

✓ Exception

• Mistake

✓ Error

• Exclusion

• Warning

✓ Alert

Q17: In what circumstances would the Marketing Authorisation Holder change the status of their product in the EMVO? Select all applicable options.

✓ Recall

✓ Theft

✓ Withdrawal

✓ Sampling

✓ Repackaging/relabelling of products

Q18: Falsified products may:

contain ingredients of low quality or in the wrong doses. be deliberately and fraudulently mislabelled with respect to their identity or source. have fake packaging, the wrong ingredients or low levels of active ingredients.

✓ True

• False

Q19: When was the FMD rolled out in Europe?

✓ February 2019

• March 2019

• May 2019

Q20: Complete the following statement:

"EU FMD covers prescription medicines and a _______ of over-the-counter (OTC) medicines that are deemed to be at a high risk of falsification."

• Bluelist

• Whitelist

✓ Blacklist

Q21: Who is responsible for ensuring that their products bear the required safety features?

✓ The Manufacturing Authorisation Holder

• The Contract Manufacturer

Q22: What category/classification of medicine displays the compulsory FMD safety features?

• GSL

✓ POM

• P

Q23: Which of the following uploads the unique identifier to the European Hub?

• The Marketing Authorisation Holder

• The Parallel Distributor

• The On-Boarding Partner

Q24: The anti-tampering device is checked at all steps of the supply chain to ensure that it's intact. If at any point it is found to not be intact it can still be supplied to the patient.

• True

✓ False

Q25: Which articles in The Delegated Regulation (EU) 2016/161 relate specifically to the verification of the safety features on medicines packaging?

• Articles 7 & 8

• Articles 8 & 9

• Articles 9 & 10

✓ Articles 10 & 11

Q26: The NMVS holds the relevant serialisation data for the European Market.

• True

✓ False

Q27: The European Hub is managed by the EMVO and consists of how many system interfaces?

• 1

✓ 2

• 3

Q28: What does the abbreviation OBP stand for?

• On-Boarding Person

• On-Boarding Party

✓ On-Boarding Partner

Q29: Which of the following is the UK Medicines Verification Organisation, a non-profit organisation set up to establish the UK's Medicines Verification System?

• Tracelink UK

✓ SecureMed UK

• Serialogical

• PharmaData Ltd

Q30: If a medicinal product triggers an error code when being checked by a wholesaler which process within their quality system would you expect them to follow?

• Complaints

✓ Deviation

✓ Quarantine

• Goods Out

Q31: WDA holders need to scan products when:

The medicines change hands but do not change storage sites. They are distributed to another site owned by the wholesaler.

• True

✓ False

Q32: Who would assist in and control an investigation into the reason for an alert being triggered when decommissioning a pack of medicinal product within a pharmacy/hospital setting?

• The Pharmacy

• The Hospital

✓ The National Competent Authority

• The Wholesaler

• The Manufacturer

Q33: Would a pharmaceutical product, being exported outside the EU need to be decommissioned by the wholesaler?

✓ Yes

• No

Q34: Many 'false positive' alerts are being triggered due to medicinal products manufactured before 9 February 2019 not being uploaded to the repositories system and some generic medicine packs, that have a 2D data matrix, not being FMD-compliant.

✓ True

• False

Q35: Which two EU countries are yet to implement the 2D barcode UI system?

• Finland

✓ Italy

• Hungary

✓ Greece

• Ireland

Q36: Active substance importation into the EU must now be accompanied by written confirmation, from the competent authority of the exporting country, that the standards of GMP and control of the manufacturing site are equivalent to those required in the EU.

✓ True

• False

Quiz: Falsified Medicines

Q1: The definition of 'falsified medicine' was introduced in order to differentiate it from other illegal products knows as '_____________ medicines.'

• Forged

✓ Counterfeit

• Imitation

Q2: Which organisation co-ordinates Operation Pangea?

• Scotland Yard

• Federal Bureau of Investigation

✓ Interpol

Q3: What do the abbreviations 'EMVS' and 'NMVS' stand for in the FMD?

✓ European Medicines Verification System

✓ National Medicines Verification System

• European Marketing Verification System

• National Marketing Verification System

Q4: Under the FMD, all new packs of prescription medicines put on the market from 9th February 2019 have to have two safety features:

a UI and an ATD. What do these abbreviations mean?

✓ Unique Identifier

• Unique Instruction

• Anti-Tinkering Device

✓ Anti-Tampering Device

Q5: Which article in The Delegated Regulation (EU) 2016/161 states which structure the repositories system should adopt?

• Article 35

• Article 33

✓ Article 32

• Article 34

Q6: Linkage of batch data within the European Hub is required for what reason?

• The decommissioning of the pharmaceutical product at any point in the legal supply chain.

✓ For when relabelling or repackaging occurs.

• The ability to run multiple verification queries of the database.

Q7: The EMVO is responsible for the setting up and running of the European Hub. It is devised, funded and run by stakeholders of the pharmaceutical industry which include which of the below:

• Dentists

✓ Wholesalers

✓ Original Pack Manufacturers

✓ Hospitals and Hospital Pharmacists

✓ Parallel Distributors

• Opticians

✓ Pharmacists

• Schools

Q8: Which of the following are the responsibilities of the National Competent Authority with regards to the FMD?

✓ To contribute to the management of the national repository.

• To supervise the functioning of the European Hub and inspect if required.

✓ To ensure compliance with the FMD as part of their routine inspections.

✓ To share reports with the EMVO.

Q9: Each time the 2D barcode is scanned through the supply chain and the NMVS confirms the status of the product, this is called:

• Confirmation

• Corroboration

✓ Verification

• Substantiation

Q10: Which of the following use 'aggregated codes' when decommissioning pharmaceutical products?

✓ Pharmacy

• Wholesaler

✓ Prisons

✓ Schools

• Pharmacists

✓ Opticians

✓ Dentists

• Other Wholesalers

✓ 10

• 14

• 8

• 12

Q13: Who must immediately be informed of medicinal products identified as falsified or suspected of being falsified?

• European Medicines Agency

✓ Marketing Authorisation Holder

• Heads of Medicines Agency

✓ National Competent Authority

• 1.0%

• 2.0%

✓ 0.05%

Q15: To comply with the requirements of the Falsified Medicines Directive distance sellers of medicines must do what?

✓ Display the common EU logo, that has been adopted for sites that sell medicines at a distance.

✓ Provide the contact details of the body with which the service is registered

✓ Display a hyperlink to the national website of the Member State in which that business is established.

• Sell only general sale list medicines.

Q16: There are three terms that are used to describe the process through which an alert is triggered. What are these?

• Mistake

✓ Error

✓ Alert

• Warning

• Exclusion

✓ Exception

Q17: In what circumstances would the Marketing Authorisation Holder change the status of their product in the EMVO? Select all applicable options.

✓ Theft

✓ Repackaging/relabelling of products

✓ Recall

✓ Withdrawal

✓ Sampling

✓ True

• False

Q19: When was the FMD rolled out in Europe?

✓ February 2019

• March 2019

• May 2019

Q20: Complete the following statement:

"EU FMD covers prescription medicines and a _______ of over-the-counter (OTC) medicines that are deemed to be at a high risk of falsification."

• Bluelist

• Whitelist

✓ Blacklist

Q21: Who is responsible for ensuring that their products bear the required safety features?

✓ The Manufacturing Authorisation Holder

• The Contract Manufacturer

Q22: What category/classification of medicine displays the compulsory FMD safety features?

• GSL

✓ POM

• P

Q23: Which of the following uploads the unique identifier to the European Hub?

• The Marketing Authorisation Holder

• The Parallel Distributor

• The On-Boarding Partner

Q24: The anti-tampering device is checked at all steps of the supply chain to ensure that it's intact. If at any point it is found to not be intact it can still be supplied to the patient.

• True

✓ False

Q25: Which articles in The Delegated Regulation (EU) 2016/161 relate specifically to the verification of the safety features on medicines packaging?

• Articles 7 & 8

• Articles 8 & 9

• Articles 9 & 10

✓ Articles 10 & 11

Q26: The NMVS holds the relevant serialisation data for the European Market.

• True

✓ False

Q27: The European Hub is managed by the EMVO and consists of how many system interfaces?

• 1

✓ 2

• 3

Q28: What does the abbreviation OBP stand for?

• On-Boarding Person

• On-Boarding Party

✓ On-Boarding Partner

Q29: Which of the following is the UK Medicines Verification Organisation, a non-profit organisation set up to establish the UK's Medicines Verification System?

• Tracelink UK

✓ SecureMed UK

• Serialogical

• PharmaData Ltd

Q30: If a medicinal product triggers an error code when being checked by a wholesaler which process within their quality system would you expect them to follow?

• Complaints

✓ Deviation

✓ Quarantine

• Goods Out

Q31: WDA holders need to scan products when:

The medicines change hands but do not change storage sites. They are distributed to another site owned by the wholesaler.

• True

✓ False

Q32: Who would assist in and control an investigation into the reason for an alert being triggered when decommissioning a pack of medicinal product within a pharmacy/hospital setting?

• The Pharmacy

• The Hospital

✓ The National Competent Authority

• The Wholesaler

• The Manufacturer

Q33: Would a pharmaceutical product, being exported outside the EU need to be decommissioned by the wholesaler?

✓ Yes

• No

✓ True

• False

Q35: Which two EU countries are yet to implement the 2D barcode UI system?

• Finland

✓ Italy

• Hungary

✓ Greece

• Ireland

✓ True

• False

GDP Awareness Training

Quiz: GDP AWARENESS TRAINING POST-TEST

Q1: As a minimum, which two pieces of documentation are essential for the accreditation of a pharmaceutical wholesaler?

• HSE Certificate

✓ WDA

• Fire & Safety Certification

• Hygiene Certification

✓ GDP Certificate

Q2: How would you define what a ‘Deviation’ is?

• Using a Fork Lift Truck instead of a hand pallet truck to move goods

• An alternative way of interpreting instruction

✓ When something departs from an established course or accepted standard

Q3: Why is pagination so important in documentation?

• It makes the Document look tidy

✓ To ensure a document can be deemed complete

• It helps with finding the right page

Q4: What does the acronym “WDA” stand for? Select 2.

• Wholesale Drug handling Agency

• World Distribution Agency

✓ Wholesale Dealer Authorisation

✓ Wholesale Distribution Authorisation

Q5: “QMS” is another common acronym in Good Distribution Practice. What do the letters stand for?

✓ Quality Management System

• Quota Management Software

• Quality Managed Supply

Q6: What does the acronym “RP” stand for?

• responsible person | 1

Q7: What TWO distinct categories do complaints fall into?

• Unnecessary

✓ Quality

• Written

• Verbal

✓ Service

Q8: Who should be ensuring quality is maintained throughout the GDP processes?

• The management

• The MHRA

✓ The Responsible Person

• The License Holder

Q9: What is the required duration for retaining GDP records/documents?

• 12 months

• 7 years

✓ 5 years

• Until termination of business

Q10: The MHRA are the UK competent authority. What do the letters stand for?

✓ Medicines and Healthcare products Regulatory Agency

• Medicinal Human Research Association

• Medicine and Health Alert Agency

Q11: What is the recommended method for paginating the pages of all documents?

• Using Alphabetical Letters

✓ "Page X of Y"

• Roman Numerals

Q12: What constitutes the most rigorous form of due diligence you could perform on a prospective customer or supplier?

• View credentials of the Management

✓ Site Visit & Audit

• Companies House Register Check

• Dinner Date to meet the management

Q13: If you make a correction in a document and it’s not clear what it is or why, how should you make it clear?

✓ Add a note explaining the change

• Hand a memo to the RP

• Use correction fluid and over-write

Q14: What does the acronym “CAPA” stand for?

• Concerted Action to Prevent Aberration

• Correct and Proceed Again

✓ Corrective Action Preventive Action

Q15: How should you correct an error in a GDP-related document, according to Good Distribution Practice guidelines?

✓ Strike through the error, correct it, initial and date it.

• Apply Correction Fluid and overwrite it.

• Write in pencil so that errors can be rubbed out and re-written.

Q16: What is “Identifying potential risks to the product's quality, ensuring actions can be taken to reduce the risk”, otherwise known as?

• Corporate Risk Mitigation

✓ Quality Risk Management

• Quota Regulation Management

Q17: What does the acronym ALCOA stand for, in relation to Data Integrity?

• A = {attributable | 1} L = {legible | 1} C = {contemporaneous | 1} O = {original | 1} A = {accurate | 1}

Q18: With respect to pharmaceutical wholesaling, what does the acronym “GDP” stand for?

• Gross Domestic Production

• General Distribution Priority

✓ Good Distribution Practice

Q19: Is it acceptable for deviations to take place?

• yes

• depends on the magnitude of the deviation

✓ yes, as long it’s documented and learned from.

• No, never

Q20: Enter the missing word from this quote by W. E. Deming.

• “If you cannot describe what you are doing as a {process | 2}, then you don’t know what you are doing”.

Q21: What three key components form the primary elements of a Quality Management System?

• Clean Uniformed Staff

✓ People

✓ Quality Risk Management

• Large Customer Base

✓ Processes (SOPs)

• Forms & Records

• Rigid Disciplinary Procedures

Q22: “SOP” is an acronym or set of initials. What do they stand for?

• Simplified Operations Protocol

• Software Operating Program

✓ Standard Operating Procedure

Q23: What are the three primary goals of Good Distribution Practice (GDP)?

• High Turnover

✓ Product Quality and Integrity

• Good Profit Margin

✓ Patient Safety

• Keeping a broad range of products

✓ Interception and Prevention of Falsified Medicines entering the supply chain

Q24: Who is able to suggest a modification or change?

• The RP Only

✓ Anyone within the GDP process

• Management

• The MHRA

Q25: According to the official definition, what are the three ways in which a medicine can be falsified?

• colour

✓ identity

• size

• weight

✓ source

• shape

✓ history

Quiz: GDP AWARENESS TRAINING PRE-TEST

Q1: What does the acronym “WDA” stand for? Select 2.

• Wholesale Drug handling Agency

• World Distribution Agency

✓ Wholesale Dealer Authorisation

✓ Wholesale Distribution Authorisation

Q2: “QMS” is another common acronym in Good Distribution Practice. What do the letters stand for?

✓ Quality Management System

• Quota Management Software

• Quality Managed Supply

Q3: What TWO distinct categories do complaints fall into?

• Unnecessary

✓ Quality

• Written

• Verbal

✓ Service

Q4: What does the acronym “RP” stand for?

• responsible person | 1

Q5: What is the required duration for retaining GDP records/documents?

• 12 months

• 7 years

✓ 5 years

• Until termination of business

Q6: Who should be ensuring quality is maintained throughout the GDP processes?

• The management

• The MHRA

✓ The Responsible Person

• The License Holder

Q7: What is the recommended method for paginating the pages of all documents?

• Using Alphabetical Letters

✓ "Page X of Y"

• Roman Numerals

Q8: The MHRA are the UK competent authority. What do the letters stand for?

✓ Medicines and Healthcare products Regulatory Agency

• Medicinal Human Research Association

• Medicine and Health Alert Agency

Q9: If you make a correction in a document and it’s not clear what it is or why, how should you make it clear?

✓ Add a note explaining the change

• Hand a memo to the RP

• Use correction fluid and over-write

Q10: What constitutes the most rigorous form of due diligence you could perform on a prospective customer or supplier?

• View credentials of the Management

✓ Site Visit & Audit

• Companies House Register Check

• Dinner Date to meet the management

Q11: How should you correct an error in a GDP-related document, according to Good Distribution Practice guidelines?

✓ Strike through the error, correct it, initial and date it.

• Apply Correction Fluid and overwrite it.

• Write in pencil so that errors can be rubbed out and re-written.

Q12: What does the acronym “CAPA” stand for?

• Concerted Action to Prevent Aberration

• Correct and Proceed Again

✓ Corrective Action Preventive Action

Q13: What does the acronym ALCOA stand for, in relation to Data Integrity?

• A = {attributable | 1} L = {legible | 1} C = {contemporaneous | 1} O = {original | 1} A = {accurate | 1}

Q14: What is “Identifying potential risks to the product's quality, ensuring actions can be taken to reduce the risk”, otherwise known as?

• Corporate Risk Mitigation

✓ Quality Risk Management

• Quota Regulation Management

Q15: According to the official definition, what are the three ways in which a medicine can be falsified?

• colour

✓ identity

• size

• weight

✓ source

• shape

✓ history

Q16: With respect to pharmaceutical wholesaling, what does the acronym “GDP” stand for?

• Gross Domestic Production

• General Distribution Priority

✓ Good Distribution Practice

Q17: Is it acceptable for deviations to take place?

• yes

• depends on the magnitude of the deviation

✓ yes, as long it’s documented and learned from.

• No, never

Q18: Enter the missing word from this quote by W. E. Deming.

• “If you cannot describe what you are doing as a {process | 2}, then you don’t know what you are doing”.

Q19: What three key components form the primary elements of a Quality Management System?

• Clean Uniformed Staff

✓ People

✓ Quality Risk Management

• Large Customer Base

✓ Processes (SOPs)

• Forms & Records

• Rigid Disciplinary Procedures

Q20: “SOP” is an acronym or set of initials. What do they stand for?

• Simplified Operations Protocol

• Software Operating Program

✓ Standard Operating Procedure

Q21: What are the three primary goals of Good Distribution Practice (GDP)?

• High Turnover

✓ Product Quality and Integrity

• Good Profit Margin

✓ Patient Safety

• Keeping a broad range of products

✓ Interception and Prevention of Falsified Medicines entering the supply chain

Q22: Who is able to suggest a modification or change?

• The RP Only

✓ Anyone within the GDP process

• Management

• The MHRA

Q23: As a minimum, which two pieces of documentation are essential for the accreditation of a pharmaceutical wholesaler?

• HSE Certificate

✓ WDA

• Fire & Safety Certification

• Hygiene Certification

✓ GDP Certificate

Q24: How would you define what a ‘Deviation’ is?

• Using a Fork Lift Truck instead of a hand pallet truck to move goods

• An alternative way of interpreting instruction

✓ When something departs from an established course or accepted standard

Q25: Why is pagination so important in documentation?

• It makes the Document look tidy

✓ To ensure a document can be deemed complete

• It helps with finding the right page

GDP Awareness Webinar Assessments

Quiz: GDP Assessment Pre-Test

Q1: What does WDA stand for?

• WDA:

{}

Q2: In which three ways can a medicine be falsely represented?

• Its Packaging

✓ Its Source

✓ Its Identity

• Its Ingredients

✓ Its History

• Its Information Leaflet

Q3: What does QMS stand for?

• QMS:

{quality management system}

Q4: What does FMD stand for?

• Fake Medical Devices

• Falsified Medicine Directory

✓ Falsified Medicines Directive

• Fake Medicines Directive

Q5: What does MHRA stand for?

• MHRA:

{}

Q6: What two things do packs of medicines need to be compliant with the FMD?

• Braille

✓ Tamper Evident Seal

• Child Proof Packaging

✓ Unique Identifying Code

Q7: What does RP stand for?

• RP:

{responsible person}

Q8: How long must GDP records/documents be kept for?

• At least 3 years

• At least 10 years

✓ At least 5 years

• At least 7 years

Q9: What are the three main elements of a QMS?

✓ Responsibilities

• Premises

• Health & Safety

✓ Processes

• Documentation

✓ Quality Risk Management

Q10: Why is version control of documents important?

• So that it is clear how many versions have existed

• To make file names clearer

• For compliance

✓ To ensure the correct version is used

Q11: In relation to data integrity, what does each letter in ALCOA stand for?

• A{} L{} C{} O{} A{}

Q12: What logo allows you to check whether a website providing medicines is genuine?

✓ GPhC Registered Pharmacy Logo

• MHRA Logo

• Companies House Logo

• EudraGMDP Logo

Q13: In GDP, how should you correct an error on a GDP-related document?

• Put a label/sticker over the top with the right details and sign it

• Reprint the document with a new version and destroy the old one

✓ Strike through the error, correct it, initial and date it

• Reprint the document with a new version and archive the old one

• Tippex the error and correct

Q14: Why is pagination important in a document?

• To protect data integrity

✓ To ensure the document can be deemed complete

• So that you know how many pages there are

• To ensure compliance with guidelines

Q15: If it is not clear why you made a correction in a document, what should you do?

• Explain it verbally to the RP/relevant personnel

• Shred the document and start over

✓ Make a note explaining the change

• Send an email explanation and save the email

Q16: What does GDP stand for in relation to pharmaceutical wholesaling?

• GDP:

{good distribution practice}

Q17: How should you paginate a document?

• Page X

✓ Page X of Y

Q18: Is it OK for deviations to occur?

• No, the MHRA could revoke your WDA

✓ Yes, as long as they are correctly documented and learnt from

Q19: What is a deviation?

• When you make a mistake that impacts compliance

• An unplanned change in procedure due to a problem

✓ When something departs from an established course or accepted standard

• An action that needs to be reported

Q20: What does CAPA mean?

• Correct, Accurate, Positive and Attributable

• Current Action, Past Action

✓ Corrective Action, Preventive Action

• Correction Activity, Prevention Activity

Q21: What are the two main objectives of GDP?

✓ Product Quality

• Availability

✓ Patient Safety

• Good Customer Service

• Best Pricing

Q22: Who can recommend a change?

• The RP

• The Quality Team

• Senior Management

✓ Anyone

Q23: Who is responsible for maintaining quality?

• The RP

✓ Everybody in the company

• Management and Supervisors

• The MHRA

Q24: What two documents are required at minimum to qualify a medicines wholesaler?

• Financial References

• Proof of VAT Number

✓ WDA

• Credit Report

✓ GDP Certificate

• Letter of Incorporation

Q25: What is Quality Risk Management

• Ensuring risks are minimised so that no personnel are injured.

• Ensuring that no risky business practices are carried out that could lead to financial loss.

✓ Identifying any potential risks to the product's quality ensuring actions can be taken to reduce the risk.

• Complying with health and safety regulations, making changes where required.

Q26: What is the strongest act of due diligence that can be carried out?

• Credit Check

✓ Site Visit/Audit

• Asking the MHRA

• Business Reference Check

Q27: What does SOP stand for?

• SOP:

{}

Q28: What are the two types of complaint?

• Packaging

✓ Product Quality

✓ Service/Distribution

• Breakage

• Customer Service

Quiz: GDP Awareness Webinar Post-Assessment

Q1: What does WDA stand for?

• WDA:

{ }

Q2: Who can recommend a change?

• The RP

• The Quality Team

✓ Anyone working within the QMS

• Senior Management

Q3: What does QMS stand for?

• QMS:

{quality management system}

Q4: What two documents are required at minimum to qualify a medicines wholesaler?

• Financial References

• Proof of VAT Number

✓ WDA license

• Credit Report

✓ GDP Certificate

• Letter of Incorporation

Q5: What does MHRA stand for?

• MHRA:

{ }

Q6: What is the strongest act of due diligence that can be carried out?

• Credit Check

✓ Site Visit/Audit

• Asking the MHRA

• Business Reference Check

Q7: What does RP stand for?

• RP:

{ responsible person }

Q8: What are the two types of complaint?

• Packaging

✓ Product Quality

✓ Service/Distribution

• Breakage

Q9: What are the two main objectives of GDP?

✓ Product Quality

• Availability

✓ Patient Safety

• Good Customer Service

• Best Pricing

Q10: In which three ways can a medicine be falsely represented?

• Packaging

✓ Source

✓ Identity

• Ingredients

✓ History

• Information Leaflet

Q11: What are the three main elements of a QMS?

✓ Responsibilities

• Premises

• Health & Safety

✓ Processes

• Documentation

✓ Quality Risk Management

Q12: What does FMD stand for?

• Fake Medical Devices

• Falsified Medicine Directory

✓ Falsified Medicines Directive

• Fake Medicines Directive

Q13: Who is responsible for maintaining quality?

✓ Everybody in the company

• The RP

• Management and Supervisors

• The MHRA

Q14: What two things do packs of medicines need to be compliant with the FMD?

• Braille

✓ Tamper Evident Seal

• Child Proof Packaging

✓ Unique Identifying Code

Q15: In relation to data integrity, what does ALCOA stand for?

• A{} L{} C{} O{} A{}

Q16: How long must GDP records/documents be kept for?

• At least 3 years

• At least 10 years

✓ At least 5 years

• At least 7 years

Q17: What is Quality Risk Management?

• Ensuring risks are minimised so that no personnel are injured.

✓ Identifying potential risks to the product's quality ensuring actions can be taken to reduce the risk.

• Ensuring that no risk business practices are carried out that could lead to financial loss.

• Complying with health & safety regulations, making changes where required.

Q18: Why is version control of documents important?

• So that it is clear how many versions have existed

✓ To ensure the correct version is used

• For compliance

• To make file names clearer

Q19: In GDP, how should you correct an error in a GDP-related document?

• Put a label/sticker over the top with the right details and sign it

✓ Strike through the error, correct it, initial and date it

• Reprint the document with a new version and destroy the old one

• Tippex the error and correct

• Reprint the document with a new version and archive the old one

Q20: What logo allows you to check whether a website providing medicine is genuine?

✓ GPhC Registered Pharmacy Logo

• Companies House Logo

• EudraGMDP Logo

• EU Common Logo

Q21: If it's not clear why you made a correction in a document, what should you do?

• Explain it verbally to the RP or relevant personnel

• Shred the document and start over

✓ Make a note explaining the change

• Send an email explanation and save the email

Q22: How should you paginate a document?

• Page X

✓ Page X of Y

Q23: Why is pagination important in a document?

• To protect data integrity

✓ To ensure a document can be deemed complete

• So that you know how many pages there are

• To ensure compliance with guidelines

Q24: What is a deviation?

• When you make a mistake that impacts compliance

• An unplanned change in procedure due to a problem

✓ When something departs from an established course or accepted standard

• An action that needs to be reported

Q25: What does GDP stand for in relation to pharmaceutical wholesaling?

• GDP:

{good distribution practice}

Q26: Is it OK for deviations to occur?

✓ Yes, as long as they are correctly documented and learnt from

• No, the MHRA could revoke your WDA

Q27: What does SOP stand for?

• SOP:

{}

Q28: What does CAPA mean?

• Correct, Accurate, Positive and Attributable

• Current Action, Past Action

✓ Corrective Action, Preventive Action

• Correction Activity, Prevention Activity

GDP for RPs and Management

Quiz: Good Distribution Practice Pre-Test

Q1: What does GDP stand for?

• {good distribution practice}

Q2: What guideline of the International Conference of Harmonisation (ICH) covers Quality Risk Management?

✓ Q9

• Q4-Q4B

• Q13

• Q11

Q3: For how long do GDP records need to be kept?

• At least 7 years

✓ At least 5 years

• At least 3 years

• Forever

Q4: How could you segregate stock in the warehouse to reduce the risk of picking errors? Choose three

✓ Put them in separate bins or locations

✓ Store similar products separately

• Mark each box with a pen and store in alphabetical order as per the product or brand

✓ Ensure that segregation is clear on all computer systems

Q5: Which six are responsibilities of an RP as per the EU Guidance 2013/C 343/01?

✓ Ensuring the QMS is implemented and maintained

✓ Keeping appropriate records of delegated duties

• Approving all new members of staff

✓ Carrying out self-inspections

✓ Ensuring initial and continuous training is given to all personnel

✓ Ensuring that customer complaints are dealt with effectively

✓ Approving returns to saleable stock

✓ Approving subcontracted activities

Q6: When should staff receive GDP training?

• After successful completion of their probationary period and then continuously

• Within their first few days and then continuously

✓ Before commencing any tasks and then continuously

• Anytime within their first few weeks and then continuously

Q7: Choose two occasions where staff should be re-trained.

✓ After errors have occurred

• Just before an inspection

• When personnel leave

✓ If there is a change to their job description and duties

Q8: In the event of a temperature excursion/deviation in your storage area, what should you do? Select four

• Wait until the quality meeting to raise the issue

✓ Inform the RP

✓ Document a deviation

✓ Record/estimate the length of the excursion,

• Tell the MHRA Defective Medicines Report Centre

✓ Take remedial actions to resolve the excursion

• Write a Yellow Card report

Q9: Receiving and dispatch bays should offer protection from what?

✓ Prevailing weather conditions

• Contamination

• Pests

• Mix-ups/confusions

Q10: What four things should specifically be prohibited in the storage areas of wholesalers?

• Hygiene Products

✓ Food

✓ Smoking materials

• Mobile Phones

✓ Drink

• Personal Bags/Belongings

✓ Personal Medication

Q11: Choose four important things you should check when receiving a delivery.

• That the delivery vehicle will ensure easy transfer of the products

✓ The address on the delivery

✓ That all packages are present

✓ The driver’s ID

✓ The data logger to see whether there were any excursions

• The driver’s licence

Q12: What does SOP stand for?

• {}

Q13: What is the acceptable temperature range (in Celsius) for cold chain products?

• 0-8

• 2-10

• 0-6

✓ 2-8

Q14: Choose two circumstances where you should re-map a fridge.

✓ If the shelves in the fridge have been moved

✓ If the fridge has been serviced

• When putting a new product in the fridge

✓ If the fridge is moved

Q15: How many suitable reference points should your thermometer/logger/ system be calibrated to?

• 5

✓ 3

• 6

• 2

Q16: Which 4 letter principle relating to product expiry dates should goods be stored under
– what does it mean?

✓ FEFO
– First Expiry, First Out

• FIFO
– First In, First Out

Q17: How do you qualify a UK pharmacy?

• Through the MHRA

✓ Through the GPhC

• Through the DMRC

Q18: Choose three ways you can approve/bona fide an EU wholesale supplier.

• Care and Quality Commission

• MHRA DMRC

✓ EUDRA GMDP

✓ Post-inspection close-out letter

• GPhC

✓ GDP Certificate

Q19: How can a product be considered falsified? Choose three.

✓ Its History

• Its Ingredients

✓ Its Identity

• Incorrect printing

• Its Packaging

✓ Its Source

Q20: What do the letters CAPA stand for?

• Correct, Accurate, Positive, Attributable

✓ Corrective Action, Preventive Action

• Current Action, Past Action

• Correction Activity, Prevention Activity

Q21: Select the correct definition for ‘Correction’ and ‘Corrective Action’.

✓ Correction:

Remove the nonconformity to make the product/service acceptable for use.

• Corrective Action:

Remove the nonconformity to make the product/service acceptable for use.

• Correction:

Correct the root cause of the problem so it doesn't occur again.

✓ Corrective Action:

Correct the root cause of the problem so it doesn't occur again.

Q22: Who can recommend a change to the QMS?

✓ All Personnel

• Only the RP

• The RP and Licence Holder

• Senior Management

Q23: What does WDA stand for?

• {}

Q24: What are the two main reasons why goods must be stored off the floor?

✓ Risk of contamination

• Risk of them being moved out of the way resulting in mix-ups

✓ To reduce the risk of temperature excursion

• To ensure they are not forgotten about during picking, reducing waste

Q25: What is the name of the MHRA website for reporting fake/faulty medicines and devices, and adverse reactions?

• MHRA Red Card

• MHRA Report Centre

• MHRA DMRC

✓ MHRA Yellow Card

Q26: How long do you have to complete a Class 2 recall?

• 24 hours

• 36 hours

✓ 48 hours

• 72 hours

Q27: What are the 2 classifications of complaint in GDP?

• Personnel/Customer Service

• Packaging

✓ Product Quality

✓ Service/Distribution

• Major

• Minor

Q28: Who must be the final arbitrator of complaints in GDP?

✓ The RP

• Senior Management

• The head of customer service

• The head of the department of which the complaint is about

Q29: What is the MHRA DMRC?

• Where destruction of medicines are reported

✓ Where defective medicines are reported.

• Where distribution of medicines is registered

• Where drivers register to be able to transport medicinal products

Q30: What is the purpose of a self-inspection, as per Chapter 8 of the EU Guidance 2013/C 343/01?

• To detect problems before they escalate

✓ To measure compliance and suggest improvements

• To assess and evaluate the performance of all personnel

• To see what can be added to the company to increase profits/business

Q31: What is the maximum time that a transit point can hold goods without having their own WDA? Select 1 answer for ambient and 1 for chilled

• Ambient:

24 hours

✓ Ambient:

36 hours

• Ambient:

48 hours

✓ Chilled:

0 hours

• Chilled:

6 hours

• Chilled:

12 hours

Q32: When organising transport without temperature control, what should be in place ahead of shipping product?

• Curtain sided vehicle to permit airflow

• Temperature mapping of the uncontrolled vehicle

✓ A transport risk assessment

Q33: Can a licensed broker procure and supply medicines?

• Yes

✓ No

Q34: What does QMS stand for?

• {quality management system}

Q35: What does MHRA stand for?

• {}

Q36: What does RP stand for?

• {responsible person}

Q37: Who is responsible for the quality system, as stated in the EU Guidance?

• RP

• Licence Holder

✓ Senior Management

• All Personnel

Q38: Choose four things that should be covered in a management review.

✓ Anything that may enhance the quality system

• A review of the RP's performance

✓ Measurement of the achievements of the quality systems objectives

✓ Any changes to business objectives and environment

✓ Assessment of performance indicators

Q39: Why is there a requirement for adequate separation between receipt, dispatch and storage areas?

• To help maintain hygiene standards in these areas

✓ To prevent cross contamination of products and picking errors

• To reduce the risk of theft and/or damage to the products

• To help with maintaining the correct conditions for products, e.g. temperature

Quiz: GDP for RPs and Management – Online – Post Test

Q1: What does GDP stand for?

• {good distribution practice}

Q2: What guideline of the International Conference of Harmonisation (ICH) covers Quality Risk Management?

✓ Q9

• Q4-Q4B

• Q13

• Q11

Q3: For how long do GDP records need to be kept?

• At least 7 years

✓ At least 5 years

• At least 3 years

• Forever

Q4: How could you segregate stock in the warehouse to reduce the risk of picking errors? Choose three

✓ Put them in separate bins or locations

✓ Store similar products separately

• Mark each box with a pen and store in alphabetical order as per the product or brand

✓ Ensure that segregation is clear on all computer systems

Q5: Which six are responsibilities of an RP as per the EU Guidance 2013/C 343/01?

✓ Ensuring the QMS is implemented and maintained

✓ Keeping appropriate records of delegated duties

• Approving all new members of staff

✓ Carrying out self-inspections

✓ Ensuring initial and continuous training is given to all personnel

✓ Ensuring that customer complaints are dealt with effectively

✓ Approving returns to saleable stock

✓ Approving subcontracted activities

Q6: When should staff receive GDP training?

• After successful completion of their probationary period and then continuously

• Within their first few days and then continuously

✓ Before commencing any tasks and then continuously

• Anytime within their first few weeks and then continuously

Q7: Choose two occasions where staff should be re-trained.

✓ After errors have occurred

• Just before an inspection

• When personnel leave

✓ If there is a change to their job description and duties

Q8: In the event of a temperature excursion/deviation in your fridge, what should you do? Select four

• Wait until the quality meeting to raise the issue

✓ Inform the RP

✓ Document a deviation

✓ Record/estimate the length of the excursion

• Tell the MHRA Defective Medicines Report Centre

✓ Take remedial actions to resolve the excursion

• Write a Yellow Card report

Q9: Receiving and dispatch bays should offer protection from what?

✓ Prevailing weather conditions

• Contamination

• Pests

• Mix-ups/confusions

Q10: What four things should specifically be prohibited in the storage areas of wholesalers?

• Hygiene Products

✓ Food

✓ Smoking materials

• Mobile Phones

✓ Drink

• Personal Bags/Belongings

✓ Personal Medication

Q11: Choose four important things you should check when receiving a delivery.

• That the delivery vehicle will ensure easy transfer of the products

✓ The address on the delivery

✓ That all packages are present

✓ The driver’s ID

✓ The data logger to see whether there were any excursions

• The driver’s licence

Q12: What does SOP stand for?

• {}

Q13: What is the acceptable temperature range (in Celsius) for cold chain products?

• 0-8

• 2-10

• 0-6

✓ 2-8

Q14: Choose two circumstances where you should re-map a fridge.

✓ If the shelves in the fridge have been moved

✓ If the fridge has been serviced

• When putting a new product in the fridge

✓ If the fridge is moved

Q15: How many suitable reference points should your thermometer/logger/ system be calibrated to?

• 5

✓ 3

• 6

• 2

Q16: Which 4 letter principle relating to product expiry dates should goods be stored under
– what does it mean?

✓ FEFO
– First Expiry, First Out

• FIFO
– First In, First Out

Q17: How do you qualify a UK pharmacy?

• Through the MHRA

✓ Through the GPhC

• Through the DMRC

Q18: Choose three ways you can approve/bona fide an EU wholesale supplier.

• Care and Quality Commission

• MHRA DMRC

✓ EUDRA GMDP

✓ Post-inspection close-out letter

• GPhC

✓ GDP Certificate

Q19: How can a product be considered falsified? Choose three.

✓ Its History

• Its Ingredients

✓ Its Identity

• Incorrect printing

• Its Packaging

✓ Its Source

Q20: What do the letters CAPA stand for?

• Correct, Accurate, Positive, Attributable

✓ Corrective Action, Preventive Action

• Current Action, Past Action

• Correction Activity, Prevention Activity

Q21: Select the correct definition for ‘Correction’ and ‘Corrective Action’.

✓ Correction:

Remove the nonconformity to make the product/service acceptable for use.

• Corrective Action:

Remove the nonconformity to make the product/service acceptable for use.

• Correction:

Correct the root cause of the problem so it doesn't occur again.

✓ Corrective Action:

Correct the root cause of the problem so it doesn't occur again.

Q22: Who can recommend a change to the QMS?

✓ All Personnel

• Only the RP

• The RP and Licence Holder

• Senior Management

Q23: What does WDA stand for?

• {}

Q24: What are the two main reasons why goods must be stored off the floor?

✓ Risk of contamination

• Risk of them being moved out of the way resulting in mix-ups

✓ To reduce the risk of temperature excursion

• To ensure they are not forgotten about during picking, reducing waste

Q25: What is the name of the MHRA website for reporting fake/faulty medicines and devices, and adverse reactions?

• MHRA Red Card

• MHRA Report Centre

• MHRA DMRC

✓ MHRA Yellow Card

Q26: How long do you have to complete a Class 2 recall?

• 24 hours

• 36 hours

✓ 48 hours

• 72 hours

Q27: What are the 2 classifications of complaint in GDP?

• Personnel/Customer Service

• Packaging

✓ Product Quality

✓ Service/Distribution

• Major

• Minor

Q28: Who must be the final arbitrator of complaints in GDP?

✓ The RP

• Senior Management

• The head of customer service

• The head of the department of which the complaint is about

Q29: What is the purpose of a self-inspection, as per Chapter 8 of the EU Guidance 2013/C 343/01?

• To detect problems before they escalate

✓ To measure compliance and suggest improvements

• To assess and evaluate the performance of all personnel

• To see what can be added to the company to increase profits/business

Q30: What is the MHRA DMRC?

• Where destruction of medicines are reported

✓ Where defective medicines are reported

• Where distribution of medicines is registered

• Where drivers register to be able to transport medicinal products

Q31: What is the maximum time that a transit point can hold goods without having their own WDA? Select 1 answer for ambient and 1 for chilled

• Ambient:

24 hours

✓ Ambient:

36 hours

• Ambient:

48 hours

✓ Chilled:

0 hours

• Chilled:

6 hours

• Chilled:

12 hours

Q32: What does MHRA stand for?

• {}

Q33: What does RP stand for?

• {responsible person}

Q34: Who is responsible for the quality system, as stated in the EU Guidance?

• The RP

✓ Senior Management

• Licence Holder

• All Personnel

Q35: Choose four things that should be covered in a management review.

✓ Anything that may enhance the quality system

• A review of the RP's performance

✓ Measurement of the achievements of the quality systems objectives

✓ Any changes to business objectives and environment

✓ Assessment of performance indicators

Q36: When organising transport without temperature control, what should be in place ahead of shipping product?

• Curtain-sided vehicle to permit airflow

• Temperature mapping of the uncontrolled vehicle

✓ A transport risk assessment

Q37: Why is there a requirement for adequate separation between receipt, dispatch and storage areas?

• To help maintain hygiene standards in these areas

✓ To prevent cross contamination of products and picking errors

• To reduce the risk of theft and/or damage to the products

• To help with maintaining the correct conditions for products, e.g. temperature

Q38: Can a licensed broker procure and supply medicines?

• Yes

✓ No

GDP Licensing Requirements

Quiz: GDP Licensing Requirements: Pre-Test

Q1: As of 21st September 2015, GDP extends to and includes the sourcing, storage and transportation of Active Pharmaceutical Ingredients (APIs) and other ingredients prior to the manufacturing of medicines for human use.

✓ True

• False

Q2: A pharmaceuticals wholesaler in the UK may require which of the following authorisations? Select all applicable options.

✓ Wholesale Distribution Authorisation
- Human (H)

✓ Wholesale Distribution Authorisation
- Veterinary (V)

✓ GDP Certificate

✓ Manufacturing 'Specials' Licence

✓ Home Office Licence

• Manufacturing and Import Authorisation

Q3: Which MHRA department is responsible for processing new licences, variations, changes of ownership, terminations, cancellations, suspensions, revocations and GMP/GDP certificates?

• Defective Medicines Report Centre

• Enforcement Group

✓ Data Processing Team

• Inspection Enforcement and Standards Division

Q4: Please complete the following statement:

"When an application is made for a manufacturer or wholesale dealer authorisation, the MHRA will undertake an initial inspection followed by periodic inspections based on ____________________"

• Annual Turnover

✓ Risk Assessments

• When they are visiting other companies in the area

• Random Selection

Q5: In what circumstances would a Wholesale Dealer Authorisation not be required? Select all applicable options.

• When selling, supplying or offering for sale/supply pharmacy, prescription only, traditional herbal and GSL medicines wholesale.

• When exporting medicinal products to countries outside the EEA.

✓ When using a temporary storage site where refrigerated products are held for less than 36 hours and are transported and stored overnight in continuously refrigerated vehicles.

• To sell on medicines that you have imported from the EEA.

• To import from a non-EEA country and export to a non-EEA country.

✓ When using a temporary storage site for holding ambient products, for which the site does not have ownership, for less than 36 hours.

• Import unlicensed medicinal products from countries inside the EEA.

Q6: New WDA applications need to be made through which of the following:

• The MHRA Email System

• The MHRA Postal Address

✓ The MHRA Portal

Q7: In order to import 'unlicensed' medicines from the EEA a wholesaler must have which of the following enabled on their WDA:

• With a marketing authorisation in EEA member state(s).

✓ Without a marketing authorisation in the EEA and intended for the EEA market.

• Without a marketing authorisation in the EEA and not intended for the EEA market.

Q8: Wholesalers should be sure of the quality of all 'unlicensed' medicines obtained and request a TSE (Transmissable Spongiform Encephalopathies) statement, where applicable, from suppliers.

✓ True

• False

Q9: What is defined as export in the GDP guidelines?

• The exporting of sensitive information.

• Receiving pharmaceuticals from destinations outside the EU/EEA.

✓ The sending of pharmaceuticals to destinations outside the EU/EEA.

• The sending of pharmaceuticals to destinations inside the EU/EEA.

Q10: The term 'controlled drug' is applied to:

✓ Any drug controlled under the Misuse of Drugs Act 1971.

• Any prescription drug that is diverted to the black market for illegal use.

✓ Any drug controlled under the Misuse of Drugs Regulation 2001.

• Any drug that is only available on prescription.

Q11: What is the most common reason for referral to IAG1 for manufacturers or distributors?

✓ The identification of 'critical' deficiencies during the inspection process.

• The identification of 'major' deficiencies during the inspection process.

• The identification of a number of 'other' deficiencies during the inspection process.

Q12: What will the manufacturer/wholesaler have to complete before an MHRA inspection?

✓ GDP/GMP Compliance Report

• GDP/GMP Response Letter

• Inspection Report

Q13: What is the name of the database used to check WDAs, GDP and GMP certificates as well as registration of Active Substance manufacturers, importers and distributors?

• Eudramed

✓ EudraGMDP

• Eudralex

Q14: What are the three levels of "therapeutic similarities" defined by parallel import licences?

✓ Simple

• Natural

• Difficult

✓ Complex

• Ordinary

✓ Standard

Q15: Brokers in the UK must do which of the following:

✓ Register as a Broker for inclusion on the MHRA published UK broker register (including wholesalers who want to broker products).

✓ Pass regular GDP inspections.

✓ Only broker products that have an MA/PL.

• Appoint a responsible person.

Q16: Complete the following statement:

"MHRA inspections are prioritised for those with the ________ rating/score. Advance notice will be given, although under the short-notice inspection programme ________/________ notification may be given.

• Lowest

✓ Highest

✓ Little/no

• Ten/fourteen days

Q17: What type of variation would you submit for changes to the following:

The business processes The named person(s) The site address

✓ Standard Variation

• Administrative Variation

Q18: Which of the following are the MHRA Enforcement Action Group not responsible for?

• Illegal advertising

✓ Tracing illegal cannabis growers

• Illegal wholesaling

• Falsified medicines

✓ The registering of online pharmacies

Q19: Good Distribution Practice requires that the quality and integrity of all medicinal products must be maintained from the (1)________ to the (2)________

• (1) Wholesaler

✓ (1) Manufacturer

✓ (2) End User

• (2) Pharamcy

Q20: A product that is wholesaled in the UK must have the which of the following?

✓ Marketing Authorisation

✓ Article 126a Authorisation

✓ Certificate of Registration

✓ Traditional Herbal Registration

Q21: When was the MHRA established?

✓ 2003

• 2001

• 2007

Q22: "The MHRA makes fact-based judgements, with regard to medicines and devices, to ensure that the benefits to patients and the public justify the risks."

✓ True

• False

Q23: The MHRA inspection programme is based on what?

• Geographical Location

✓ Risk

• Annual Turnover

Q24: The establishment of the MHRA brought together the functions of the MCA and the MDA. What do these abbreviations stand for?

✓ Medicines Control Agency

• Medicines Consultation Authority

✓ Medical Devices Agency

• Medical Devices Authority

Q25: Who, within the MHRA, issues GDP and GMP certificates on behalf of the GDP and GMP Inspectorate?

• Inspection, Enforcement and Standards Division

• The Defective Medicines Report Centre

✓ The MHRA Data Processing Team

Q26: Select the ways in which an inspection can be triggered.

✓ Whistle-blower

• Random Selection

✓ Other MHRA Department

✓ Other Regulatory Authorities

Q27: Product-related GMP inspections can be requested by the European Medicines Agency (EMA).

✓ True

• False

Q28: The manufacturer or wholesaler will be given 14 days' notice of a triggered inspection.

• True

• False

Q29: MHRA Guidance Note _____ contains notes for applicants and holders of a WDA or broker registration.

• Four

• Three

✓ Six

• Five

Q30: The WDA allows the sale/supply of which of the following medicinal products?

• Controlled Drugs

✓ POM

✓ P

• Unlicensed Medicines from a Third Country

✓ Traditional Herbal Medicines

Q31: Complete the following statement:

"An applicant for a WDA will have to demonstrate that they can meet the conditions specified in Regulations _______ of the Human Medicines Regulations 2012/1916 Part 3 Conditions for holding the WDA."

• 41-43

✓ 43-45

• 42-44

• 44-46

Q32: The applicant for a WDA will have to demonstrate that they can meet the conditions specified in Regulations 43-45 of the Human Medicines Regulations 2012/1916 Part 3 Conditions for holding a WDA. This requires them to carry out which of the following:

• Compliance with GMP and a comprehensive Quality System appropriate to the activities being carried out.

✓ The services of a Responsible Person who will be named on the licence.

✓ Maintenance of appropriate and continued supply of products.

✓ Provision of suitable staff, premises, equipment and facilities for the safe handling and storage of medicinal products.

✓ Correct sourcing and supply of medicinal products.

✓ Documentation and record-keeping covering critical activities.

✓ Emergency plan and recall processes.

Q33: How many types of variation are there?

• 1

✓ 2

• 3

• 4

Q34: If a company's contact details need to be amended i.e. telephone number/email, what kind of variation would need to be submitted?

✓ Administrative Variation

• Standard Variation

Q35: The MHRA request additional information on the WDA application to ensure that the quality and safety of medicinal products will not be compromised. This additional information includes which of the following:

✓ The condition of the wholesaler premises.

✓ Whether the Quality Management System has been tailored to the wholesaler's business.

✓ How products will be transported.

✓ Whether Technical Agreements are in place with third party contractors.

✓ The temperature control and temperature monitoring of products.

Q36: Who will ultimately assess the suitability of an RP and when will this take place?

• The Company Director at an internal interview.

✓ The MHRA inspector at a site inspection.

• An MHRA panel at an arranged interview.

Q37: An RP's inability to demonstrate the required experience and knowledge or to adequately carry out duties, could mean that they are removed from the licence or that they are not accepted to be on the RP on the licence. These actions may be extended to any other licence on which the RP is named.

✓ True

• False

Q38: When supplying 'unlicensed' medicines what qualifies as a patient's 'special' need?

• Financial need

• The need of convenience

✓ Clinical need

Q39: A minimum of how many days' written notice must be given to the MHRA prior to import of an 'unlicensed' medicine from outside the EEA?

• 10

• 14

• 21

✓ 28

Q40: In order to import 'unlicensed' medicines from outside the EEA a wholesaler must have which of the following in addition to a WDA:

• A manufacture/import authorisation

✓ A manufacturer 'specials' licence

Q41: Wholesalers should be sure of the quality of all 'unlicensed' medicines obtained and request certificates of ___________ or ___________

• Consistency

✓ Authenticity

✓ Conformance

• Accuracy

Q42: Unlicensed medicines with the lowest risk are most likely to be obtained from which of the following?

✓ The EEA

• Third Countries

✓ Countries with Mutual Recognition Agreements

✓ The USA

Q43: What guidelines regulate export activities outside the EEA?

• EU GDP Guidelines

• WHO Guidelines only

✓ WHO Guidelines and the country's own GDP Guidelines

Q44: Human medicines export to non-EU countries requires the wholesaler to hold a WDA enable for 'Export'.

✓ True

• False

Q45: The export of certain drugs in execution by lethal injection are under EU-wide control. Appropriate permission, to export these drugs, must be sought by UK exporters, from which organisation?

• The MHRA

✓ The UK Export Control Organisation

• The Home Office

• The Foreign Office

Q46: What additional licence is required to legalise the supply of controlled drugs by a wholesaler?

• Manufacturer/import licence

• Manufacturer 'specials' licence

✓ A Home Office licence

• Manufacturer licence for investigational medicinal products

Q47: If there are significant concerns about a site's compliance but there is no direct evidence of a critical deficiency, or the need to recommend regulatory actions, what action would be taken by the MHRA?

✓ Referral to the Compliance Management Team

• Referral to the IAG1 or IAG2

• Referral to the MHRA Enforcement Action Group

Q48: Which groups advise MHRA's Director of IE&S on recommendations for regulatory action?

✓ IAG1 & IAG2

• The MHRA Enforcement Action Group

• The Compliance Management Team

Q49: At what time frame does the MHRA carry out a second inspection of a company?

✓ 9 months post initial inspection

• 12 months post initial inspection

• 18 months post inspection

Q50: Select the areas, within a wholesale business, on which an MHRA inspection team will focus.

✓ Stock and stock management

✓ Pharmaceutical storage area

• Catering facilities

✓ Temperature monitoring

✓ Returns area

• Reception area

✓ Purchasing and sales functions

Q51: Which of the following are used as terminology by the MHRA for types of nonconformity?

• Medium

✓ Critical

• Minimal

✓ Other

✓ Major

• Serious

Q52: When registered as a broker in the UK, what are the three things that a broker does not do?

• Use a QMS

✓ Buy or sell products

✓ Physically handle the product

✓ Own the products

Quiz: Good Distribution Practice Licensing Requirements

✓ True

• False

Q2: A pharmaceuticals wholesaler in the UK may require which of the following authorisations? Select all applicable options.

✓ Wholesale Distribution Authorisation
- Human (H)

✓ Wholesale Distribution Authorisation
- Veterinary (V)

✓ GDP Certificate

✓ Manufacturing 'Specials' Licence

✓ Home Office Licence

• Manufacturing and Import Authorisation

Q3: Which MHRA department is responsible for processing new licences, variations, changes of ownership, terminations, cancellations, suspensions, revocations and GMP/GDP certificates?

• Defective Medicines Report Centre

• Enforcement Group

✓ Data Processing Team

• Inspection Enforcement and Standards Division

• Annual Turnover

✓ Risk Assessments

• Random Selection

• When they are visiting other companies in the area

Q5: In what circumstances would a Wholesale Dealer Authorisation not be required? Select all applicable options.

• When selling, supplying or offering for sale/supply pharmacy, prescription only, traditional herbal and GSL medicines wholesale.

• When exporting medicinal products to countries outside the EEA.

✓ When using a temporary storage site where refrigerated products are held for less than 36 hours and are transported and stored overnight in continuously refrigerated vehicles.

• To sell on medicines that you have imported from the EEA.

• To import from a non-EEA country and export to a non-EEA country.

✓ When using a temporary storage site for holding ambient products, for which the site does not have ownership, for less than 36 hours.

• Import unlicensed medicinal products from countries inside the EEA.

Q6: New WDA applications need to be made through which of the following:

• The MHRA Email System

• The MHRA Postal Address

✓ The MHRA Portal

Q7: In order to import 'unlicensed' medicines from the EEA a wholesaler must have which of the following enabled on their WDA:

• With a marketing authorisation in EEA member state(s).

✓ Without a marketing authorisation in the EEA and intended for the EEA market.

• Without a marketing authorisation in the EEA and not intended for the EEA market.

Q8: Wholesalers should be sure of the quality of all 'unlicensed' medicines obtained and request a TSE (Transmissable Spongiform Encephalopathies) statement, where applicable, from suppliers.

✓ True

• False

Q9: What is defined as export in the GDP guidelines?

• The exporting of sensitive information.

• Receiving pharmaceuticals from destinations outside the EU/EEA.

✓ The sending of pharmaceuticals to destinations outside the EU/EEA.

• The sending of pharmaceuticals to destinations inside the EU/EEA.

Q10: The term 'controlled drug' is applied to:

✓ Any drug controlled under the Misuse of Drugs Act 1971.

• Any prescription drug that is diverted to the black market for illegal use.

✓ Any drug controlled under the Misuse of Drugs Regulation 2001.

• Any drug that is only available on prescription.

Q11: What is the most common reason for referral to IAG1 for manufacturers or distributors?

✓ The identification of 'critical' deficiencies during the inspection process.

• The identification of 'major' deficiencies during the inspection process.

• The identification of a number of 'other' deficiencies during the inspection process.

Q12: What will the manufacturer/wholesaler have to complete before an MHRA inspection?

✓ GDP/GMP Compliance Report

• GDP/GMP Response Letter

• Inspection Report

Q13: What is the name of the database used to check WDAs, GDP and GMP certificates as well as registration of Active Substance manufacturers, importers and distributors?

• Eudramed

✓ EudraGMDP

• Eudralex

Q14: What are the three levels of "therapeutic similarities" defined by parallel import licences?

✓ Simple

• Natural

• Difficult

✓ Complex

✓ Standard

• Ordinary

Q15: Brokers in the UK must do which of the following:

✓ Register as a Broker for inclusion on the MHRA published UK broker register (including wholesalers who want to broker products).

✓ Only broker products that have an MA/PL.

• Appoint a responsible person.

✓ Pass regular GDP inspections.

✓ Highest

• Lowest

• Ten/fourteen days

✓ Little/no

Q17: What type of variation would you submit for changes to the following:

The business processes The named person(s) The site address

✓ Standard Variation

• Administrative Variation

Q18: Which of the following are the MHRA Enforcement Action Group not responsible for?

✓ The registering of online pharmacies

• Illegal wholesaling

✓ Tracing illegal cannabis growers

• Illegal advertising

• Falsified medicines

Q19: Good Distribution Practice requires that the quality and integrity of all medicinal products must be maintained from the (1)________ to the (2)________

• (1) Wholesaler

✓ (1) Manufacturer

✓ (2) End User

• (2) Pharmacy

Q20: A product that is wholesaled in the UK must have the which of the following?

✓ Marketing Authorisation

✓ Article 126a Authorisation

✓ Certificate of Registration

✓ Traditional Herbal Registration

Q21: When was the MHRA established?

✓ 2003

• 2001

• 2007

Q22: "The MHRA makes fact-based judgements, with regard to medicines and devices, to ensure that the benefits to patients and the public justify the risks."

✓ True

• False

Q23: The MHRA inspection programme is based on what?

• Geographical Location

✓ Risk

• Annual Turnover

• Random Selection

Q24: The establishment of the MHRA brought together the functions of the MCA and the MDA. What do these abbreviations stand for?

✓ Medicines Control Agency

• Medicines Consultation Authority

✓ Medical Devices Agency

• Medical Devices Authority

Q25: Who, within the MHRA, issues GDP and GMP certificates on behalf of the GDP and GMP Inspectorate?

• Inspection, Enforcement and Standards Division

• The Defective Medicines Report Centre

✓ The MHRA Data Processing Team

Q26: Select the ways in which an inspection can be triggered.

✓ Whistle-blower

• Random Selection

✓ Other MHRA Department

✓ Other Regulatory Authorities

Q27: Product-related GMP inspections can be requested by the European Medicines Agency (EMA).

✓ True

• False

Q28: The manufacturer or wholesaler will be given 14 days' notice of a triggered inspection.

• True

✓ False

Q29: MHRA Guidance Note _____ contains notes for applicants and holders of a WDA or broker registration.

• Four

• Three

✓ Six

• Five

Q30: The WDA allows the sale/supply of which of the following medicinal products?

• Controlled Drugs

✓ POM

✓ P

• Unlicensed Medicines from a Third Country

✓ Traditional Herbal Medicines

• 41-43

✓ 43-45

• 42-44

• 44-46

• Compliance with GMP and a comprehensive Quality System appropriate to the activities being carried out.

✓ The services of a Responsible Person who will be named on the licence.

✓ Maintenance of appropriate and continued supply of products.

✓ Provision of suitable staff, premises, equipment and facilities for the safe handling and storage of medicinal products.

✓ Correct sourcing and supply of medicinal products.

✓ Documentation and record-keeping covering critical activities.

✓ Emergency plan and recall processes.

Q33: How many types of variation are there?

• 1

✓ 2

• 3

• 4

Q34: If a company's contact details need to be amended i.e. telephone number/email, what kind of variation would need to be submitted?

✓ Administrative Variation

• Standard Variation

✓ The condition of the wholesaler premises.

✓ Whether the Quality Management System has been tailored to the wholesaler's business.

✓ How products will be transported.

✓ Whether Technical Agreements are in place with third party contractors.

✓ The temperature control and temperature monitoring of products.

Q36: Who will ultimately assess the suitability of an RP and when will this take place?

• The Company Director at an internal interview.

✓ The MHRA inspector at a site inspection.

• An MHRA panel at an arranged interview.

✓ True

• False

Q38: When supplying 'unlicensed' medicines what qualifies as a patient's 'special' need?

• Financial need

• The need for convenience

✓ Clinical need

Q39: A minimum of how many days' written notice must be given to the MHRA prior to import of an 'unlicensed' medicine from outside the EEA?

• 10

• 14

• 21

✓ 28

Q40: In order to import 'unlicensed' medicines from outside the EEA a wholesaler must have which of the following in addition to a WDA:

• A manufacture/import authorisation

✓ A manufacturer 'specials' licence

Q41: Wholesalers should be sure of the quality of all 'unlicensed' medicines obtained and request certificates of ___________ or ___________

• Consistency

✓ Authenticity

✓ Conformance

• Accuracy

Q42: Unlicensed medicines with the lowest risk are most likely to be obtained from which of the following?

✓ The EEA

• Third Countries

✓ Countries with Mutual Recognition Agreements.

✓ The USA.

Q43: What guidelines regulate export activities outside the EEA?

• EU GDP Guidelines

• WHO Guidelines only

✓ WHO Guidelines and the country's own GDP Guidelines

Q44: Human medicines export to non-EU countries requires the wholesaler to hold a WDA enable for 'Export'.

✓ True

• False

• The MHRA

✓ The UK Export Control Organisation

• The Home Office

• The Foreign Office

Q46: What additional licence is required to legalise the supply of controlled drugs by a wholesaler?

• Manufacturer/import licence

• Manufacturer 'specials' licence

✓ A Home Office licence

• Manufacturer licence for investigational medicinal products

✓ Referral to the Compliance Management Team

• Referral to the IAG1 or IAG2

• Referral to the MHRA Enforcement Action Group

Q48: Which groups advise MHRA's Director of IE&S on recommendations for regulatory action?

✓ IAG1 & IAG2

• The MHRA Enforcement Action Group

• The Compliance Management Team

Q49: At what time frame does the MHRA carry out a second inspection of a company?

✓ 9 months post initial inspection

• 12 months post initial inspection

• 18 months post inspection

Q50: Select the areas, within a wholesale business, on which an MHRA inspection team will focus.

✓ Stock and stock management

✓ Pharmaceutical storage area

• Catering facilities

✓ Temperature monitoring

✓ Returns area

• Reception area

✓ Purchasing and sales functions

Q51: Which of the following are used as terminology by the MHRA for types of nonconformity?

• Medium

✓ Critical

• Minimal

✓ Other

✓ Major

• Serious

Q52: When registered as a broker in the UK, what are the three things that a broker does not do?

• Use a QMS

✓ Buy or sell products

✓ Physically handle the product

✓ Own the products

GDP Obligations of the Licence Holder

Quiz: Obligations of the Licence Holder – pretest

Q1: What is the purpose of segregating medicinal products in a GDP warehouse?

• To maximise space

• To improve operations

✓ To separate saleable stock from stock awaiting final disposition decisions

• To reduce the amount of time it takes to pick and pack orders

Q2: When can a WDA Licence Holder begin wholesale activity

• As soon as the WDA application has been submitted

• As soon as premises are ready to store medicines

✓ Only after the WDA has been granted by the MHRA

• As soon as the first medicines arrive into stock

Q3: What is the core purpose of the GDP Quality Management System? (Tick all that apply)

• Maximising sales

✓ Ensuring medicines and consistently stored, handled and distributed in accordance with documented storage conditions

✓ Protecting patient safety and public health

• Reducing the workload of staff

Q4: Who is ultimately responsible for authorising the release of returned medicinal products for re-distribution?

• The Warehouse Manager

✓ The Responsible Person

• The Commercial Director

• The Licence Holder

Q5: If medicinal products are purchased from an approved supplier, there is no need to perform falsified medicine checks on the products.

• True

✓ False

Q6: Once the Responsible Person is appointed the Licence Holder plays no part in the management of the Quality Management System.

• True

✓ False

Q7: What must be established to monitor the movement of medicinal products?

• Sales strategy

✓ A traceability system

• A returns policy

• A recall budget

Q8: If an MHRA inspector turns up at my site unannounced I can refuse entry as they haven’t given me prior notice.

• True

✓ False

Q9: An unknown supplier, who has thousands of followers on LinkedIn offers medicines at a really good price and will allow my organisation to have a larger profit margin if we order immediately. Can I place the order?

• Yes

✓ No

Q10: Once the Responsible Person is appointed the Licence Holder plays no part in the management of the Quality Management System.

• True

✓ False

Q11: Can a WDA be suspended by the MHRA?

• No

✓ Yes

Q12: What must be in place when outsourcing a GPD activity?

• A verbal agreement

✓ A written agreement

• A purchase order

• Nothing, outsourcing is not permitted

Q13: Which of the following can a WDA (H) holder legally supply medicinal products to? (tick all that apply)

• A member of the general public

✓ Another WDA holder

✓ A registered pharmacy

• A veterinary practice

Q14: As long as the Responsible Person has completed a Cogent Gold Standard Responsible Person training course, no further assessments are required.

• True

✓ False

Q15: Who appoints the Responsible Person?

• The Director

• The Quality Manager

• The Human Resources Manager

✓ The Licence Holder

Q16: Who is responsible for ensuring there are sufficient staff to carryout Good Distribution Practice (GDP) activities?

• The Quality Manager

• The Responsible Person

✓ The Licence Holder

• The Director

Q17: Following Brexit, the UK no longer needs to comply with EU GDP Guidelines.

• True

✓ False

Q18: Which part of the Human Medicines Regulations 2012 sets out the obligations of the Licence Holder?

• Part 3, Chapter 2, Section 44

• Part 3, Chapter 2, Section 18

✓ Part 3, Chapter 2, Section 43

• Schedule 6, Part 2

Q19: The obligations of a Licence Holder are set out in which piece of legislation?

• Rules and Guidance for Pharmaceutical Distributors

• EU GDP Guidelines

✓ Human Medicines Regulations 2012

Q20: Who is responsible for ensuring GDP compliance within a WDA Licence Holder’s operation?

• The Warehouse Manager

• The Operations Director

✓ The Responsible Person

• The Chairman

Q21: What legislation must WDA holders comply with? (tick all that apply)

✓ Human Medicines Regulations

✓ GDP Guidelines

✓ GMP Guidelines

✓ EU Community Code

• ISO 9001

• Health Products Regulatory Authority

Q22: Who issues WDA licences in the UK?

• The Home Office

✓ The Medicines and Healthcare products Regulatory Agency

• The National Institute of Clinical Excellence

• The NHS

Q23: What is the primary purpose of a WDA?

• Manufacturing medicines

• Importing medicinal devices

✓ Wholesale distribution of medicinal products

• Selling medicines to patients

Q24: In order to supply medicines for human use a pharmaceutical wholesaler must be in possession of a….

• WDA(V)

✓ WDA(H)

• Controlled Drug Licence

• MIA

• MS

Quiz: Obligations of the Licence Holder – Post Test

Q1: What is the purpose of segregating medicinal products in a GDP warehouse?

• To maximise space

• To improve operations

✓ To separate saleable stock from stock awaiting final disposition decisions

• To reduce the amount of time it takes to pick and pack orders

Q2: When can a WDA Licence Holder begin wholesale activity

• As soon as the WDA application has been submitted

• As soon as premises are ready to store medicines

✓ Only after the WDA has been granted by the MHRA

• As soon as the first medicines arrive into stock

Q3: What is the core purpose of the GDP Quality Management System? (Tick all that apply)

• Maximising sales

✓ Ensuring medicines and consistently stored, handled and distributed in accordance with documented storage conditions

✓ Protecting patient safety and public health

• Reducing the workload of staff

Q4: Who is ultimately responsible for authorising the release of returned medicinal products for re-distribution?

• The Warehouse Manager

✓ The Responsible Person

• The Commercial Director

• The Licence Holder

Q5: If medicinal products are purchased from an approved supplier, there is no need to perform falsified medicine checks on the products.

• True

✓ False

Q6: Once the Responsible Person is appointed the Licence Holder plays no part in the management of the Quality Management System.

• True

✓ False

Q7: What must be established to monitor the movement of medicinal products?

• Sales strategy

✓ A traceability system

• A returns policy

• A recall budget

Q8: If an MHRA inspector turns up at my site unannounced I can refuse entry as they haven’t given me prior notice.

• True

✓ False

• Yes

✓ No

Q10: Once the Responsible Person is appointed the Licence Holder plays no part in the management of the Quality Management System.

• True

✓ False

Q11: Can a WDA be suspended by the MHRA?

• No

✓ Yes

Q12: What must be in place when outsourcing a GPD activity?

• A verbal agreement

✓ A written agreement

• A purchase order

• Nothing, outsourcing is not permitted

Q13: Which of the following can a WDA (H) holder legally supply medicinal products to? (tick all that apply)

• A member of the general public

✓ Another WDA holder

✓ A registered pharmacy

• A veterinary practice

Q14: As long as the Responsible Person has completed a Cogent Gold Standard Responsible Person training course, no further assessments are required.

• True

✓ False

Q15: Who appoints the Responsible Person?

• The Director

• The Quality Manager

• The Human Resources Manager

✓ The Licence Holder

Q16: Who is responsible for ensuring there are sufficient staff to carryout Good Distribution Practice (GDP) activities?

• The Quality Manager

• The Responsible Person

✓ The Licence Holder

• The Director

Q17: Following Brexit, the UK no longer needs to comply with EU GDP Guidelines.

• True

✓ False

Q18: Which part of the Human Medicines Regulations 2012 sets out the obligations of the Licence Holder?

• Part 3, Chapter 2, Section 44

• Part 3, Chapter 2, Section 18

✓ Part 3, Chapter 2, Section 43

• Schedule 6, Part 2

Q19: The obligations of a Licence Holder are set out in which piece of legislation?

• Rules and Guidance for Pharmaceutical Distributors

• EU GDP Guidelines

✓ Human Medicines Regulations 2012

Q20: Who is responsible for ensuring GDP compliance within a WDA Licence Holder’s operation?

• The Warehouse Manager

• The Operations Director

✓ The Responsible Person

• The Chairman

Q21: What legislation must WDA holders comply with? (tick all that apply)

✓ Human Medicines Regulations

✓ GDP Guidelines

✓ GMP Guidelines

✓ EU Community Code

• ISO 9001

• Health Products Regulatory Authority

Q22: Who issues WDA licences in the UK?

• The Home Office

✓ The Medicines and Healthcare products Regulatory Agency

• The National Institute of Clinical Excellence

• The NHS

Q23: What is the primary purpose of a WDA?

• Manufacturing medicines

• Importing medicinal devices

✓ Wholesale distribution of medicinal products

• Selling medicines to patients

Q24: In order to supply medicines for human use a pharmaceutical wholesaler must be in possession of a….

• WDA(V)

✓ WDA(H)

• Controlled Drug Licence

• MIA

• MS

Good Distribution Practice – Change Control

Quiz: Change Control – Pre Test

Q1: What Is A Change Control?

✓ A formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner

• A formal process for identifying root cause

• A formal process for complaint handling

• A formal process for implementing CAPAs

Q2: Which of the following relates to a Change Control?

• An unplanned change which appears as a deviation from processes and procedures

✓ A planned change is defined as a change which is documented, reviewed, assessed and approved by relevant personnel prior to conducting the related activity

Q3: Why Is A Change Control Required? (select all that apply)

✓ Regulatory expectation

✓ Facilitates continuous improvement

• Reduces the frequency of deviations

✓ Enables an assessment of risk of the proposed change

Q4: What are the consequences of a non-compliant or absent Change Control System? (select all that apply)

✓ Missing audit trail and evidence of change

✓ Non effective implementation and confusion

✓ Increased risk to product quality and patient safety

✓ Increase in errors and lack of control of the systems and processes within an organisation

Q5: Change Controls must cover any planned activity which results in a change to any GxP activity i.e., regulated by an authority (MHRA, FDA etc.). Select the changes below that warrant a Change Control.

✓ A new distribution warehouse

✓ Upgrade of IT system

✓ Introduction of new medicinal storage equipment

✓ a personnel change; where a new warehouse operative has joined a company

Q6: An evaluation of the potential risk of the proposed change must be assessed. Name four categories that are typically considered when a change is proposed?

• Health and Safety

✓ Products

✓ Procedures

• Environmental

✓ People

✓ Processes

Q7: Classify the below statement as Minor, Major or a Critical Change Control. "The change control affects a quality attribute, a process parameter, an equipment or instrument that is employed for process or control, of which the impact to the end-user (or personnel or environment) is highly probable, including life threatening situations."

• Major

✓ Critical

• Minor

Q8: Who Is Responsible For Assigning CAPA Actions?

• QA

• HR

✓ Subject Matter Expert (SME)

• Qualified Person (QP)/Responsible Person (RP)

Q9: What Are Some Of Responsibilities of An Action Owner? (select all that apply)

✓ Completing actions in the timeframes allocated

✓ Ensuring that appropriate evidence is available for action closure

✓ Completion of action extension form in the event the action cannot be completed on time

• Approve the Change Control

Q10: Who Assigns The Change Control Classification?

✓ QA

• Subject Matter Expert (SME)

• HR

• Plant/Warehouse Management

Quiz: Change Control – Post Test

Q1: Who Assigns The Change Control Classification?

✓ QA

• Subject Matter Expert (SME)

• HR

• Plant/Warehouse Management

Q2: What Are Some Of Responsibilities of An Action Owner? (select all that apply)

✓ Completing actions in the timeframes allocated

✓ Ensuring that appropriate evidence is available for action closure

✓ Completion of action extension form in the event the action cannot be completed on time

• Approve the Change Control

Q3: Who Is Responsible For Assigning CAPA Actions?

• QA

• HR

✓ Subject Matter Expert (SME)

• Qualified Person (QP)/Responsible Person (RP)

Q4: Classify the below statement as Minor, Major or a Critical Change Control. "The change control affects a quality attribute, a process parameter, an equipment or instrument that is employed for process or control, of which the impact to the end-user (or personnel or environment) is highly probable, including life threatening situations."

• Major

✓ Critical

• Minor

Q5: An evaluation of the potential risk of the proposed change must be assessed. Name four categories that are typically considered when a change is proposed?

• Health and Safety

✓ Products

✓ Procedures

• Environmental

✓ People

✓ Processes

Q6: Change Controls must cover any planned activity which results in a change to any GxP activity i.e., regulated by an authority (MHRA, FDA etc.). Select the changes below that warrant a Change Control.

✓ A new distribution warehouse

✓ Upgrade of IT system

✓ Introduction of new medicinal storage equipment

✓ a personnel change; where a new warehouse operative has joined a company

Q7: What are the consequences of a non-compliant or absent Change Control System? (select all that apply)

✓ Missing audit trail and evidence of change

✓ Non effective implementation and confusion

✓ Increased risk to product quality and patient safety

✓ Increase in errors and lack of control of the systems and processes within an organisation

Q8: Why Is A Change Control Required? (select all that apply)

✓ Regulatory expectation

✓ Facilitates continuous improvement

• Reduces the frequency of deviations

✓ Enables an assessment of risk of the proposed change

Q9: Which of the following relates to a Change Control?

• An unplanned change which appears as a deviation from processes and procedures

✓ A planned change is defined as a change which is documented, reviewed, assessed and approved by relevant personnel prior to conducting the related activity

Q10: What Is A Change Control?

✓ A formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner

• A formal process for identifying root cause

• A formal process for complaint handling

• A formal process for implementing CAPAs

Protected: Good Distribution Practice and Quality Management

Quiz: GDP and Quality Management: Pre-Test

Q1: Compliance with Good Distribution Practice (GDP) Guidelines requires consistent storage, transportation and handling under the conditions required by the _______________ or ________________

• Wholesaler

✓ Marketing Authorisation

• End User

✓ Product Specification

Q2: Choose three elements of a GDP system that can be used for KPIs.

✓ Complaints

✓ Feedback on Outsourced Activities

• Temperature Mapping

• Temperature Monitoring

✓ Deviations

Q3: Complete the following statement:

"The quality system is the responsibility of the organisation's ______________ and requires their leadership and active participation and should be supported by ____________ commitment."

• Warehouse Department

• Responsible Person

✓ Management

✓ Staff

• Finance Department

Q4: The process approach includes establishing the organisation's processes needed to operate as an integrated and complete system.

✓ True

• False

Q5: The elements which make up a process are carried out in which of the following sequences?

• Outputs
- Activities
- Inputs

• Inputs
- Outputs
- Activities

✓ Inputs
- Activities
- Outputs

Q6: Which of the following could be categorised as major changes?

✓ Addition of several new product classes to WDA

• Installation of new equipment

✓ New IT systems

• Implementation of new SOPs

✓ Change in RP, key staff or Managing Director

• Purchase of new delivery van

✓ New distribution company

Q7: What two parties are involved in 'Outsourced Activities'?

✓ Contract Giver

• Contract Provider

• Contract Receiver

✓ Contract Acceptor

Q8: Complete the following statement:

"The outcome of each management review should be _____________ in a timely manner and effectively ____________ internally."

• Filed

✓ Documented

• Discussed

✓ Communicated

Q9: Risk assessment involves identifying, analysing and prioritising the risks.

✓ True

• False

Q10: Chapter 1.5 of the GDP Guidelines (2013/C 343/01) contains a reference to ICH ____ which is a guideline dealing with Quality Risk Management for Medicinal Products.

• Q7

• Q8

✓ Q9

• Q10

Q11: When building the Quality Management System, who is responsible for identifying key issues affecting the business and creating policy that addresses those issues and commits to continuous improvement?

• The RP

• Company Employees

✓ Management

Q12: The boundaries of the Quality Management System include which of the following?

• Types of products provided/not provided

✓ Commercial policies and strategies

✓ In-house or outsourced activities

✓ Infrastructure of the organisation including different sites and activities

Q13: What should a pharmaceutical wholesaler's Quality Manual contain? Select all applicable options.

• Process Flowchart

• Organisational Chart

✓ Temperature Mapping Reports

✓ Staff Training Records

Q14: Risk Reduction may include which of the following strategies?

✓ Avoidance

✓ Mitigation

• Transmissions

• Exploration

✓ Acceptance

Q15: The main focus of the Quality System is ______________ and ______________.

• Company Profit

✓ Patient Safety

✓ Product Quality

• Employee Satisfaction

Q16: How many chapters are there in the European GDP Guidelines 2013/C 343/01?

• 7

• 8

• 9

✓ 10

Q17: Which of the following two groups of subject headings are included, as chapters, in the European GDP Guidelines?

• Quality Management; Premises and Equipment; Operations; Transportation

• Brokers; Operating Guidelines; Inspections; Documents

Q18: Who are responsible for identifying the key issues affecting their business?

• Staff

✓ Management

• The Responsible Person

Q19: What should a pharmaceutical wholesaler's Quality Manual contain?

• Process Flowchart

• Organisational Chart

✓ Temperature Mapping Records

✓ Staff Training Records

Q20: Complete the following statement:

"A controlled document is a __________ document which, through the course of its ________, may be reviewed, modified and ___________ several times."

✓ Reference

• Library

✓ Lifecycle

• Existence

✓ Distributed

• Printed

Q21: What is the meaning of SMART in relation to quality objectives?

✓ Specific, Measurable, Achievable, Realistic, Timely

• Special, Meaning, Achievable, Relatable, Tasks

• Specific, Measurable, Achievable, Real, Tasks

Q22: What is meant by a KPI?

✓ Key Performance Indicators

• Key Practice Identifier

• Key Process Information

Q23: What does PDCA mean in relation to processes and their interactions with risk-based thinking?

• Prepare-Document-Check-Acknowledge

✓ Plan-Do-Check-Act

• Produce-Document-Circulate-Act

Q24: Internal training, leadership and performance evaluation can be regarded as a process.

✓ True

• False

Q25: Which of the following can be categorised as tangible outputs?

• Information

✓ Materials

• Data

✓ Components

✓ Equipment

• Knowledge

Q26: Which of the following can be used as tools for documenting processes?

✓ Process flows

✓ Charts

✓ Videos

✓ Checklists

Q27: It may be necessary, to conduct validation of a critical process during routine activities. The term for this is ___________

• Prospective Validation

✓ Concurrent Validation

• Retrospective Validation

Q28: What stage of process validation is the PQ stage?

• Process Quotation

• Process Quantification

✓ Process Qualification

Q29: There are seven basic quality tools which can be used in conjunction with the PDCA cycle. Choose four of these from the following list.

• Pie Chart

✓ Flow Chart

✓ Histogram

• Evaluation Plan

✓ Pareto Diagram

• Baseline Survey

• Thematic Analysis

✓ Control Chart

Q30: Who, within a business, can suggest a change?

• Management

✓ Anyone

Q31: Which of the following would be defined as a 'Change' in a wholesale business?

✓ Introducing a new process

✓ Redesigning the warehouse pharmaceutical storage area

✓ Changes to an existing process

✓ Buying a new refrigerator for storing medicines

✓ Moving a pharmaceutical wholesaling business to a new site

Q32: Are the following stages of the change control process in the correct order? Close/Gain Acceptance Suggest Plan Build/Test Implement Review Assess

• Yes

✓ No

Q33: How does a Wholesaler Distributor define, agree and control outsourced activities?

✓ Technical agreement or written contract defining the roles and responsibilities of each party.

• A verbal agreement which defines the roles and responsibilities of each party.

Q34: The Quality Management System should not extend to the control and review of any outsourced activities relating to the procurement, holding, supply or export of medicinal products.

• True

✓ False

Q35: Control of Outsourced Activities should incorporate quality risk management that requires which of the following?

✓ Assessing the suitability and competence of the contract acceptor to carry out the activity and checking authorisation where required

✓ Defining the responsibilities and communication processes for the quality related activities of the parties involved

✓ Monitoring and review of the performance of the contract acceptor and the identification and implementation of required improvements on a regular basis

Q36: Who should have a formal process in place for reviewing the quality system on a periodic basis?

• The organisation's employees

✓ The organisation's management

• The organisation's contractors

Q37: Which of the management representatives should be present at the management review meetings, where possible, to report on and discuss areas of concern?

• Warehouse Management

✓ The Responsible Person

• Sales Department Management

• Finance Department Management

Q38: An ineffective QMS can cause staff to become motivated.

• True

✓ False

Q39: When was the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) created?

• 1992

✓ 1990

• 1991

• 1994

Q40: Good Distribution Practice requires that the evaluation of the risk to quality should be based on scientific knowledge. What is meant by 'scientific knowledge' in this context?

• Knowledge of scientific processes

✓ Experience with the process

Q41: Quality Risk Management is:

"A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle."

✓ True

• False

Q42: Complete the following statement:

"Utilising risk-based thinking means that the QMS becomes ________ rather than _________ in preventing or reducing non-conformances through early identification and action."

✓ Reactive

• Inactive

✓ Proactive

• Interactive

Q43: Tools such as the 'Qualitative Risk Assessment', 'what if' questions and the application of brainstorming techniques cannot be used as effective tools for the application of risk-based thinking.

• True

✓ False

Q44: Risk Assessment involves identifying, analysing and prioritising the risks.

✓ True

• False

Q45: For risk management and review you should ensure that you do which of the following?

✓ Check the effectiveness of the actions carried out

✓ Periodically review identified risks

✓ Work to identify new risks (both internal and external)

✓ Ensure proper execution of risk treatments

✓ Learn from your experiences and make a commitment to continuous improvement

Quiz: Good Distribution Practice and Quality Management

Q1: Compliance with Good Distribution Practice (GDP) Guidelines requires consistent storage, transportation and handling under the conditions required by the _______________ or ________________

• Wholesaler

✓ Marketing Authorisation

• End User

✓ Product Specification

Q2: Choose three elements of a GDP system that can be used for KPIs.

✓ Complaints

✓ Feedback on Outsourced Activities

• Temperature Monitoring

✓ Deviations

• Temperature Mapping

✓ Management

• Responsible Person

• Warehouse Department

• Finance Department

✓ Staff

Q4: The process approach includes establishing the organisation's processes needed to operate as an integrated and complete system.

✓ True

• False

Q5: The elements which make up a process are carried out in which of the following sequences?

• Outputs
- Activities
- Inputs

✓ Inputs
- Activities
- Outputs

• Inputs
- Outputs
- Activities

Q6: Which of the following could be categorised as major changes?

✓ Addition of several new product classes to WDA

• Installation of new equipment

✓ New IT systems

• Implementation of new SOPs

✓ Change in RP, key staff or Managing Director

✓ New distribution company

• Purchase of new delivery van

Q7: What two parties are involved in 'Outsourced Activities'?

• Contract Provider

✓ Contract Giver

• Contract Receiver

✓ Contract Acceptor

Q8: Complete the following statement:

"The outcome of each management review should be _____________ in a timely manner and effectively ____________ internally."

✓ Documented

• Filed

• Discussed

✓ Communicated

Q9: Risk assessment involves identifying, analysing and prioritising the risks.

✓ True

• False

Q10: Chapter 1.5 of the GDP Guidelines (2013/C 343/01) contains a reference to ICH ____ which is a guideline dealing with Quality Risk Management for Medicinal Products.

• Q10

• Q7

✓ Q9

• Q8

✓ Management

• The RP

• Company Employees

Q12: The boundaries of the Quality Management System include which of the following?

✓ Commercial policies and strategies

✓ Infrastructure of the organisation including different sites and activities

• Types of products provided/not provided

✓ In-house or outsourced activities

Q13: What should a pharmaceutical wholesaler's Quality Manual contain? Select all applicable options.

• Organisational Chart

✓ Staff Training Records

• Process Flowchart

✓ Temperature Mapping Reports

Q14: Risk Reduction may include which of the following strategies?

• Transmissions

✓ Mitigation

• Exploration

✓ Acceptance

✓ Avoidance

Q15: The main focus of the Quality System is ______________ and ______________.

✓ Patient Safety

• Employee Satisfaction

✓ Product Quality

• Company Profit

Q16: How many chapters are there in the European GDP Guidelines 2013/C 343/01?

• 7

• 8

• 9

✓ 10

Q17: Which of the following two groups of subject headings are included, as chapters, in the European GDP Guidelines?

• Quality Management; Premises and Equipment; Operations; Transportation

• Brokers; Operating Guidelines; Inspections; Documents

Q18: Who are responsible for identifying the key issues affecting their business?

• Staff

✓ Management

• The Responsible Person

Q19: What should a pharmaceutical wholesaler's Quality Manual contain?

• Process Flowchart

• Organisational Chart

✓ Temperature Mapping Records

✓ Staff Training Records

Q20: Complete the following statement:

"A controlled document is a __________ document which, through the course of its ________, may be reviewed, modified and ___________ several times."

✓ Reference

• Library

✓ Lifecycle

• Existence

✓ Distributed

• Printed

Q21: What is the meaning of SMART in relation to quality objectives?

✓ Specific, Measurable, Achievable, Realistic, Timely

• Special, Meaning, Achievable, Relatable, Tasks

• Specific, Measurable, Achievable, Real, Tasks

Q22: What is meant by a KPI?

✓ Key Performance Indicators

• Key Practice Identifier

• Key Process Information

Q23: What does PDCA mean in relation to processes and their interactions with risk-based thinking?

• Prepare-Document-Check-Acknowledge

✓ Plan-Do-Check-Act

• Produce-Document-Circulate-Act

Q24: Internal training, leadership and performance evaluation can be regarded as a process.

✓ True

• False

Q25: Which of the following can be categorised as tangible outputs?

• Information

✓ Materials

• Data

✓ Components

✓ Equipment

• Knowledge

Q26: Which of the following can be used as tools for documenting processes?

✓ Process flows

✓ Charts

✓ Videos

✓ Checklists

Q27: It may be necessary, to conduct validation of a critical process during routine activities. The term for this is ___________

• Prospective Validation

✓ Concurrent Validation

• Retrospective Validation

Q28: What stage of process validation is the PQ stage?

• Process Quotation

• Process Quantification

✓ Process Qualification

Q29: There are seven basic quality tools which can be used in conjunction with the PDCA cycle. Choose four of these from the following list.

• Pie Chart

✓ Flow Chart

✓ Histogram

• Evaluation Plan

✓ Pareto Diagram

• Baseline Survey

• Thematic Analysis

✓ Control Chart

Q30: Who, within a business, can suggest a change?

• Management

✓ Anyone

• The Responsible Person

Q31: Which of the following would be defined as a 'Change' in a wholesale business?

✓ Introducing a new process

✓ Redesigning the warehouse pharmaceutical storage area

✓ Changes to an existing process

✓ Buying a new refrigerator for storing medicines

✓ Moving a pharmaceutical wholesaling business to a new site

Q32: Are the following stages of the change control process in the correct order? Close/Gain Acceptance Suggest Plan Build/Test Implement Review Assess

• Yes

✓ No

Q33: How does a Wholesaler Distributor define, agree and control outsourced activities?

✓ Technical agreement or written contract defining the roles and responsibilities of each party.

• A verbal agreement which defines the roles and responsibilities of each party.

Q34: The Quality Management System should not extend to the control and review of any outsourced activities relating to the procurement, holding, supply or export of medicinal products.

• True

✓ False

Q35: Control of Outsourced Activities should incorporate quality risk management that requires which of the following?

✓ Assessing the suitability and competence of the contract acceptor to carry out the activity and checking authorisation where required

✓ Defining the responsibilities and communication processes for the quality related activities of the parties involved

✓ Monitoring and review of the performance of the contract acceptor and the identification and implementation of required improvements on a regular basis

Q36: Who should have a formal process in place for reviewing the quality system on a periodic basis?

• The organisation's employees

✓ The organisation's management

• The organisation's contractors

Q37: Which of the management representatives should be present at the management review meetings, where possible, to report on and discuss areas of concern?

• Warehouse Management

✓ The Responsible Person

• Sales Department Management

• Finance Department Management

Q38: An ineffective QMS can cause staff to become motivated.

• True

✓ False

Q39: When was the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) created?

• 1992

✓ 1990

• 1991

• 1994

Q40: Good Distribution Practice requires that the evaluation of the risk to quality should be based on scientific knowledge. What is meant by 'scientific knowledge' in this context?

• Knowledge of scientific processes

✓ Experience with the process

✓ True

• False

✓ Reactive

• Inactive

✓ Proactive

• Interactive

• True

✓ False

Q44: Risk Assessment involves identifying, analysing and prioritising the risks.

✓ True

• False

Q45: For risk management and review you should ensure that you do which of the following?

✓ Check the effectiveness of the actions carried out

✓ Periodically review identified risks

✓ Work to identify new risks (both internal and external)

✓ Ensure proper execution of risk treatments

✓ Learn from your experiences and make a commitment to continuous improvement

Good Distribution Practice Awareness – 2023/24

Quiz: GDP Awareness Post-Test GDPA23/24

Q1: What does GDP stand for in relation to pharmaceutical wholesaling?

• GDP:

{good distribution practice}

Q2: What is Quality Risk Management?

• Ensuring risks are minimised so that no personnel are injured.

✓ Identifying potential risks to the product's quality ensuring actions can be taken to reduce the risk.

• Ensuring that no risk business practices are carried out that could lead to financial loss.

• Complying with health & safety regulations, making changes where required.

Q3: In GDP, how should you correct an error in a GDP-related document?

• Put a label/sticker over the top with the right details and sign it

✓ Strike through the error, correct it, initial and date it

• Reprint the document with a new version and destroy the old one

• Tippex the error and correct

• Reprint the document with a new version and archive the old one

Q4: If it's not clear why you made a correction in a document, what should you do?

• Explain it verbally to the RP or relevant personnel

• Shred the document and start over

✓ Make a note explaining the change

• Send an email explanation and save the email

Q5: How should you paginate a document?

• Page X

✓ Page X of Y

Q6: Why is pagination important in a document?

• To protect data integrity

✓ To ensure a document can be deemed complete

• So that you know how many pages there are

• To ensure compliance with guidelines

Q7: What is a deviation?

• When you make a mistake that impacts compliance

• An unplanned change in procedure due to a problem

✓ When something departs from an established course or accepted standard

• An action that needs to be reported

Q8: Is it OK for deviations to occur?

✓ Yes, as long as they are correctly documented and learnt from

• No, the MHRA could revoke your WDA

Q9: What does CAPA mean?

• Correct, Accurate, Positive and Attributable

• Current Action, Past Action

✓ Corrective Action, Preventive Action

• Correction Activity, Prevention Activity

Q10: Who can recommend a change?

• The RP

• The Quality Team

✓ Anyone

• Senior Management

Q11: What does SOP stand for?

• SOP:

{}

Q12: What two documents are required at minimum to qualify a medicines wholesaler?

• Financial References

• Proof of VAT Number

✓ WDA

• Credit Report

✓ GDP Certificate

• Letter of Incorporation

Q13: What is the strongest act of due diligence that can be carried out?

• Credit Check

✓ Site Visit/Audit

• Asking the MHRA

• Business Reference Check

Q14: What are the two types of complaint?

• Packaging

✓ Product Quality

✓ Service/Distribution

• Customer Service

• Breakage

Q15: In which three ways can a medicine be falsely represented?

• Packaging

✓ Source

✓ Identity

• Ingredients

✓ History

• Information Leaflet

Q16: What does FMD stand for?

• Fake Medical Devices

• Falsified Medicine Directory

✓ Falsified Medicines Directive

• Fake Medicines Directive

Q17: What two things do packs of medicines need to be compliant with the FMD?

• Braille

✓ Tamper Evident Seal

• Child Proof Packaging

✓ Unique Identifying Code

Q18: How long must GDP records/documents be kept for?

• At least 3 years

• At least 10 years

✓ At least 5 years

• At least 7 years

Q19: Why is version control of documents important?

• So that it is clear how many versions have existed

✓ To ensure the correct version is used

• For compliance

• To make file names clearer

Q20: What does WDA stand for?

• WDA:

{}

Q21: What logo allows you to check whether a pharmacy providing medicine is genuine?

✓ GPhC Registered Pharmacy Logo

• Companies House Logo

• EudraGMDP Logo

• MHRA Logo

Q22: What does QMS stand for?

• QMS:

{quality management system}

Q23: What does MHRA stand for?

• MHRA:

{}

Q24: What does RP stand for?

• RP:

{responsible person}

Q25: What are the two main objectives of GDP?

✓ Product Quality

• Availability

✓ Patient Safety

• Good Customer Service

• Best Pricing

Q26: What are the three main elements of a QMS?

✓ Responsibilities

• Premises

• Health & Safety

✓ Processes

• Documentation

✓ Quality Risk Management

Q27: Who is responsible for maintaining quality?

✓ Everybody in the company

• The RP

• Management and Supervisors

• The MHRA

Q28: In relation to data integrity, what does each letter in ALCOA stand for?

• A{} L{} C{} O{} A{}

Quiz: GDP Awareness Pre-Test – GDPA23/24

Q1: What does GDP stand for in relation to pharmaceutical wholesaling?

• GDP:

{good distribution practice}

Q2: Who is responsible for maintaining quality?

• The RP

✓ Everybody in the company

• Management and Supervisors

• The MHRA

Q3: What is Quality Risk Management

• Ensuring risks are minimised so that no personnel are injured.

• Ensuring that no risky business practices are carried out that could lead to financial loss.

✓ Identifying any potential risks to the product's quality ensuring actions can be taken to reduce the risk.

• Complying with health and safety regulations, making changes where required.

Q4: In GDP, how should you correct an error on a GDP-related document?

• Put a label/sticker over the top with the right details and sign it

• Reprint the document with a new version and destroy the old one

✓ Strike through the error, correct it, initial and date it

• Reprint the document with a new version and archive the old one

• Tippex the error and correct

Q5: If it is not clear why you made a correction in a document, what should you do?

• Explain it verbally to the RP/relevant personnel

• Shred the document and start over

✓ Make a note explaining the change

• Send an email explanation and save the email

Q6: How should you paginate a document?

• Page X

✓ Page X of Y

Q7: Why is pagination important in a document?

• To protect data integrity

✓ To ensure the document can be deemed complete

• So that you know how many pages there are

• To ensure compliance with guidelines

Q8: What is a deviation?

• When you make a mistake that impacts compliance

• An unplanned change in procedure due to a problem

✓ When something departs from an established course or accepted standard

• An action that needs to be reported

Q9: Is it OK for deviations to occur?

• No, the MHRA could revoke your WDA

✓ Yes, as long as they are correctly documented and learnt from

Q10: What does CAPA mean?

• Correct, Accurate, Positive and Attributable

• Current Action, Past Action

✓ Corrective Action, Preventive Action

• Correction Activity, Prevention Activity

Q11: Who can recommend a change?

• The RP

• The Quality Team

• Senior Management

✓ Anyone

Q12: What does SOP stand for?

• SOP:

{}

Q13: What two documents are required at minimum to qualify a medicines wholesaler?

• Financial References

• Proof of VAT Number

✓ WDA

• Credit Report

✓ GDP Certificate

• Letter of Incorporation

Q14: What is the strongest act of due diligence that can be carried out?

• Credit Check

✓ Site Visit/Audit

• Asking the MHRA

• Business Reference Check

Q15: What are the two types of complaint?

• Packaging

✓ Product Quality

✓ Service/Distribution

• Breakage

• Customer Service

Q16: In which three ways can a medicine be falsely represented?

• Its Packaging

✓ Its Source

✓ Its Identity

• Its Ingredients

✓ Its History

• Its Information Leaflet

Q17: What does FMD stand for?

• Fake Medical Devices

• Falsified Medicine Directory

✓ Falsified Medicines Directive

• Fake Medicines Directive

Q18: What two things do packs of medicines need to be compliant with the FMD?

• Braille

✓ Tamper Evident Seal

• Child Proof Packaging

✓ Unique Identifying Code

Q19: How long must GDP records/documents be kept for?

• At least 3 years

• At least 10 years

✓ At least 5 years

• At least 7 years

Q20: Why is version control of documents important?

• So that it is clear how many versions have existed

• To make file names clearer

• For compliance

✓ To ensure the correct version is used

Q21: What logo allows you to check whether a pharmacy providing medicines is genuine?

✓ GPhC Registered Pharmacy Logo

• MHRA Logo

• Companies House Logo

• EudraGMDP Logo

Q22: What does WDA stand for?

• WDA:

{}

Q23: What does QMS stand for?

• QMS:

{quality management system}

Q24: What does MHRA stand for?

• MHRA:

{}

Q25: What does RP stand for?

• RP:

{responsible person}

Q26: What are the two main objectives of GDP?

✓ Product Quality

• Availability

✓ Patient Safety

• Good Customer Service

• Best Pricing

Q27: What are the three main elements of a QMS?

✓ Responsibilities

• Premises

• Health & Safety

✓ Processes

• Documentation

✓ Quality Risk Management

Q28: In relation to data integrity, what does each letter in ALCOA stand for?

• A{} L{} C{} O{} A{}

Good Distribution Practice: Chapters 6-10 of the EU Guidance 2013/C 343/01

Quiz: Chapter 6-10: Pre Test

Q1: What should happen to returned pharmaceutical products when first received back?

• Placed into saleable stock

✓ Placed into quarantine

• Destroyed

Q2: What is meant by the phrase 'reverse distribution' with reference to the pharmaceutical supply chain?

✓ Returned product, where fake products can be introduced.

• The decision to quarantine or dispose of returned, rejected, recalled or falsified products.

• Releasing returned products to saleable stock.

Q3: What, with a Quality Management System, does the WDA holder need to be capable of initiating at any time?

• Change Control

• Deviation

✓ Recall

• Complaint

Q4: Complete the following statement:

"When no recalls occur in a ___ month period, a dummy/mock recall must be performed to test the system."

• 6

✓ 12

• 10

• 9

Q5: What should be in place between the two parties involved in outsourced activities?

• Transport Agreement

✓ Technical Agreement

• Licensing Agreement

Q6: Who should carry out at least one self-inspection per year?

✓ Responsible Person

• Warehouse Manager

• Management

• Director

Q7: Complete the following statement:

"There should be a _________ review of all corrective actions to ensure that they have been implemented."

• Quarterly

✓ Monthly

• Annually

• Every 6 months

Q8: How would you deal with suspected falsified products? Select all applicable answers.

✓ Segregate the products immediately

• Approve destruction of stock

✓ Inform RP

✓ Document and retain records

✓ Inform MHRA

✓ Inform MA holder

Q9: Complete the following statement:

"Preventive actions are ___________"

• Active

• Inactive

✓ Proactive

• Reactive

Q10: Complete the following statement regarding transportation of medicinal products:

"Storage conditions must be _________ during transportation."

✓ Maintained

• Resorted

• Compliant

• Identified

Q11: Provisions should be made to minimise the duration of temporary storage to less than 48 hours (unless the company holding the product has a WDA), whilst awaiting the next stage of the transportation route.

• True

✓ False

Q12: Who must be made aware of every situation in which a deviation occurs, or where the temperature is beginning to trend negatively when transporting pharmaceutical products?

• Management

• Warehouse Manager

✓ The RP

• The Company Director

Q13: Anyone in the UK involved in brokering activities are required to register with which regulatory body?

✓ MHRA

• HMA

• EMA

Q14: Records of all medicinal products brokered should be kept for at least ___ years.

• 2

• 3

• 4

✓ 5

Q15: Which of the following are objectives of a self-inspection?

✓ Communicating to management any areas of concern within the business and ensuring that both these and specific GDP requirements are discussed at management review meetings.

✓ Identify areas for improvement and the implementation of CAPAs to address this.

• Evaluating the effectiveness of management.

✓ To monitor the implementation of and compliance with GDP principles and contractual requirements.

Q16: The selection of containers for transporting pharmaceutical products should be based on which of the following?

✓ Estimated maximum time for transportation.

✓ Anticipated external extremes

• The lowest cost.

✓ Transit storage time at customs

✓ Product requirements.

Q17: Counterfeit medicines are medicines that do not comply with intellectual-property rights or that infringe trademark laws.

✓ True

• False

Q18: Complete the following statement:

"There must be a pre-defined schedule in place (decided according to _______) which covers all of your GDP activities."

• Management

✓ Risk

• Availability

• Requirements

Q19: Complete the following statement:

"Complaints should be (1)_________ and (2)_________ back to (3)_________ where appropriate. Use and assess (4)_________ to (5)_________ the (6)_________ of the complaints process and (7)_________ the findings to (8)_________."

• (1)

• (2)

• (3)

• (4)

• (5)

• (6)

• (7)

• (8)

Q20: When GDP or an SOP is not followed, due to planned or unplanned reasons, what must be logged?

✓ A Deviation

• A CAPA

• A Complaint

Q21: A distinction should be made between complaints related to service and those related to distribution.

• True

✓ False

Q22: If a customer calls to talk about the packaging on a pharmaceutical product they have bought and say:

"It's badly packed again" how many complaints is the customer making?

• One

✓ Two

• Three

• Four

Q23: Brokers are not required to build and maintain a QMS.

• True

✓ False

Q24: Complete the following statement:

"The expectations of the MHRA are that products from an unlicensed site should be returned within ___ days, not 10 as stated in the EU Guidance."

• 1

• 2

• 3

• 4

✓ 5

Q25: Exported product or product that has left the UK can be accepted for return.

• True

✓ False

Q26: A falsified medicinal product can be defined as any medicinal product with a false representation of its:

Identity, including its packaging labelling, name or composition (other than unintentional quality defects) as regards any of its ingredients and the strength of those ingredients. Source, including its manufacturer, its country of manufacturing, its country of origin or its MA holder. History, including the records and documents relating to the distribution channels used.

✓ True

• False

Q27: The reporting of a falsified medicine to the MHRA can be made using which scheme?

• Red Card

✓ Yellow Card

• Blue Card

• Orange Card

Q28: Which department issues alerts when a medicine is being recalled or when there are concerns about the quality that will affect its safety or effectiveness?

✓ The Defective Medicines Report Centre

• The Damaged Medicines Report Centre

• The Deformed Medicines Report Centre

Q29: If a class 3 recall was issued, within what time frame would the required action need to be taken?

✓ 5 days

• 48 hours

• Immediately

Q30: What two parties are involved in 'Outsourced Activities'?

✓ Contract Giver

• Contract Provider

✓ Contract Acceptor

• Contract Receiver

Q31: Complete the following statement:

"________ responsibilities should be avoided as this can lead to them being missed as each party thinks that the other is carrying out that activity."

• Individual

✓ Shared

• Multiple

• Singular

Q32: Complete the following statement:

"The self-inspection team must review the outcome of the previous inspection, before commencing the current one, to determine whether _________ have been implemented."

• Outcomes

• Complaints

✓ Corrective Actions

Q33: Which of the following are types of nonconformity?

• Crucial

✓ Critical

• Medium

✓ Major

✓ Minor

• Marginal

Q34: Which of the following can be defined as a 'major' nonconformity?

• Minimal or no risk to product or service

✓ A break-down in the effectiveness of the Quality System

• Any departure from GDP that results in a significant risk to patients

Q35: Complete the following statement:

"Corrective actions are _______"

• Proactive

• Active

✓ Reactive

• Inactive

Q36: What tool can be used when identifying the root cause of a problem?

• The Five Questions

• The Five Reasons

✓ The Five Whys

Q37: Medicines need to be shipped within label conditions.

✓ True

• False

Q38: Complete the following statement:

"Any temperature ________ or product damage should be reported and ________. A _________ must be in place for this."

✓ Excursions, investigated, procedure

• Procedure, investigated, excursions

Q39: Wherever possible non-dedicated vehicles should be used for the transport of pharmaceutical products.

• True

• False

Q40: Complete the following statement:

"A contract will need to be in place with third-party transporters that encompasses the requirements from Chapter ___."

• 6

✓ 7

• 8

• 9

• 10

Q41: Equipment used for temperature monitoring during transport within vehicles and/or containers should be maintained and calibrated at regular intervals at least once every two years.

• True

✓ False

Q42: Provisions should be made to minimise the duration of temporary storage to less than 48 hours (unless the company holding the product has a WDA), whilst awaiting the next stage of the transportation route.

• True

• False

Q43: Complete the following statement:

"______ the supply chain prior to the ____ assessment. _______ in knowledge are immediately given a ______ risk".

• Investigate, risk, gaps, low

✓ Map, risk, gaps, high

• Test, product, tests, low

Q44: Complete the following statement:

"Containers should bear _________ providing sufficient information on handling and storage requirements/precautions to ensure that the products are properly handled and secured at all times."

• Sealing tape

• Protective wrapping

✓ Labels

Q45: When transporting pharmaceutical products Spring and Autumn configurations should be used and risk assessments of the routes are essential, especially when shipping internationally.

• True

✓ False

Q46: Who is ultimately responsible for ensuring that a company's export activities comply with UK GDP and legal requirements?

• The Warehouse Manager

• The Company Director

✓ The Responsible Person

Q47: Before considering exporting a pharmaceutical product you should check whether there are export controls in place, such as:

Sanctions or embargoes. Banking or financial restrictions or sanctions.

✓ True

• False

Q48: Which business organisation publishes and maintains the Intercoms listing?

• International Council of Commerce.

• International Chamber of Communication.

✓ International Chamber of Commerce.

Q49: What might a buyer in a third country require when purchasing UK exported pharmaceutical products?

• Export Licence

✓ Inport Licence

Q50: The UK exporter of pharmaceutical products is legally responsible for their correct Tariff classification. From which source can the required classification be obtained?

✓ CHIEF

• CHEEF

• CHEAF

Q51: Brokers are allowed to broker pharmaceutical products which do not have a Marketing Authorisation (MA).

• True

✓ False

Q52: Broker registration requires you to have an RP.

• True

✓ False

Quiz: Good Distribution Practice: Chapters 6-10 of the EU Guidance 2013/C 343/01

Q1: What should happen to returned pharmaceutical products when first received back?

• Placed into saleable stock

✓ Placed into quarantine

• Destroyed

Q2: What is meant by the phrase 'reverse distribution' with reference to the pharmaceutical supply chain?

✓ Returned product, where fake products can be introduced.

• The decision to quarantine or dispose of returned, rejected, recalled or falsified products.

• Releasing returned products to saleable stock.

Q3: What, with a Quality Management System, does the WDA holder need to be capable of initiating at any time?

• Change Control

• Deviation

✓ Recall

• Complaint

Q4: Complete the following statement:

"When no recalls occur in a ___ month period, a dummy/mock recall must be performed to test the system."

• 6

✓ 12

• 10

• 9

Q5: What should be in place between the two parties involved in outsourced activities?

• Transport Agreement

✓ Technical Agreement

• Licensing Agreement

Q6: Who should carry out at least one self-inspection per year?

✓ Responsible Person

• Warehouse Manager

• Management

• Director

Q7: Complete the following statement:

"There should be a _________ review of all corrective actions to ensure that they have been implemented."

• Quarterly

✓ Monthly

• Annually

• Every 6 months

Q8: How would you deal with suspected falsified products? Select all applicable answers.

✓ Segregate the products immediately

• Approve destruction of stock

✓ Inform RP

✓ Document and retain records

✓ Inform MHRA

✓ Inform MA holder

Q9: Complete the following statement:

"Preventive actions are ___________"

• Active

• Inactive

✓ Proactive

• Reactive

Q10: Complete the following statement regarding transportation of medicinal products:

"Storage conditions must be _________ during transportation."

✓ Maintained

• Restored

• Compliant

• Identified

• True

✓ False

Q12: Who must be made aware of every situation in which a deviation occurs, or where the temperature is beginning to trend negatively when transporting pharmaceutical products?

• Management

• Warehouse Manager

✓ The RP

• The Company Director

Q13: Anyone in the UK involved in brokering activities are required to register with which regulatory body?

✓ MHRA

• HMA

• EMA

Q14: Records of all medicinal products brokered should be kept for at least ___ years.

• 2

• 3

• 4

✓ 5

Q15: Which of the following are objectives of a self-inspection?

✓ Communicating to management any areas of concern within the business and ensuring that both these and specific GDP requirements are discussed at management review meetings.

✓ Identify areas for improvement and the implementation of CAPAs to address this.

• Evaluating the effectiveness of management.

✓ To monitor the implementation of and compliance with GDP principles and contractual requirements.

Q16: The selection of containers for transporting pharmaceutical products should be based on which of the following?

✓ Estimated maximum time for transportation.

✓ Anticipated external extremes

• The lowest cost.

✓ Transit storage time at customs

✓ Product requirements.

Q17: Counterfeit medicines are medicines that do not comply with intellectual-property rights or that infringe trademark laws.

✓ True

• False

Q18: Complete the following statement:

"There must be a pre-defined schedule in place (decided according to _______) which covers all of your GDP activities."

• Management

✓ Risk

• Availability

• Requirements

• (1)

• (2)

• (3)

• (4)

• (5)

• (6)

• (7)

• (8)

Q20: When GDP or an SOP is not followed, due to planned or unplanned reasons, what must be logged?

✓ A deviation

• A CAPA

• A complaint

Q21: A distinction should be made between complaints related to service and those related to distribution.

• True

✓ False

Q22: If a customer calls to talk about the packaging on a pharmaceutical product they have bought and say:

"It's badly packed again" how many complaints is the customer making?

• One

✓ Two

• Three

• Four

Q23: Brokers are not required to build and maintain a QMS.

• True

✓ False

Q24: Complete the following statement:

"The expectations of the MHRA are that products from an unlicensed site should be returned within ___ days, not 10 as stated in the EU Guidance."

• 1

• 2

• 3

• 4

✓ 5

Q25: Exported product or product that has left the UK can be accepted for return.

• True

✓ False

✓ True

• False

Q27: The reporting of a falsified medicine to the MHRA can be made using which scheme?

• Red Card

✓ Yellow Card

• Blue Card

• Orange Card

Q28: Which department issues alerts when a medicine is being recalled or when there are concerns about the quality that will affect its safety or effectiveness?

✓ The Defective Medicines Report Centre

• The Damaged Medicines Report Centre

• The Deformed Medicines Report Centre

Q29: If a class 3 recall was issued, within what time frame would the required action need to be taken?

✓ 5 days

• 48 hours

• Immediately

Q30: What two parties are involved in 'Outsourced Activities'?

✓ Contract Giver

• Contract Provider

✓ Contract Acceptor

• Contract Receiver

Q31: Complete the following statement:

"________ responsibilities should be avoided as this can lead to them being missed as each party thinks that the other is carrying out that activity."

• Individual

✓ Shared

• Multiple

• Singular

• Outcomes

• Complaints

✓ Corrective Actions

Q33: Which of the following are types of nonconformity?

• Crucial

✓ Critical

• Medium

✓ Major

✓ Minor

• Marginal

Q34: Which of the following can be defined as a 'major' nonconformity?

• Minimal or no risk to product or service

✓ A break-down in the effectiveness of the Quality System

• Any departure from GDP that results in a significant risk to patients

Q35: Complete the following statement:

"Corrective actions are _______"

• Proactive

• Active

✓ Reactive

• Inactive

Q36: What tool can be used when identifying the root cause of a problem?

• The Five Questions

• The Five Reasons

✓ The Five Whys

Q37: Medicines need to be shipped within label conditions.

✓ True

• False

Q38: Complete the following statement:

"Any temperature ________ or product damage should be reported and ________. A _________ must be in place for this."

✓ Excursions, investigated, procedure

• Procedure, investigated, excursions

Q39: Wherever possible non-dedicated vehicles should be used for the transport of pharmaceutical products.

• True

✓ False

Q40: Complete the following statement:

"A contract will need to be in place with third-party transporters that encompasses the requirements from Chapter ___."

• 6

✓ 7

• 8

• 9

• 10

Q41: Equipment used for temperature monitoring during transport within vehicles and/or containers should be maintained and calibrated at regular intervals at least once every two years.

• True

✓ False

• True

✓ False

Q43: Complete the following statement:

"______ the supply chain prior to the ____ assessment. _______ in knowledge are immediately given a ______ risk".

• Investigate, risk, gaps, low

✓ Map, risk, gaps, high

• Test, product, tests, low

• Sealing tape

• Protective wrapping

✓ Labels

Q45: When transporting pharmaceutical products Spring and Autumn configurations should be used and risk assessments of the routes are essential, especially when shipping internationally.

• True

✓ False

Q46: Who is ultimately responsible for ensuring that a company's export activities comply with UK GDP and legal requirements?

• The Warehouse Manager

• The Company Director

✓ The Responsible Person

✓ True

• False

Q48: Which business organisation publishes and maintains the Intercoms listing?

• International Council of Commerce.

• International Chamber of Communication.

✓ International Chamber of Commerce.

Q49: What might a buyer in a third country require when purchasing UK exported pharmaceutical products?

• Export Licence

✓ Import Licence

Q50: The UK exporter of pharmaceutical products is legally responsible for their correct Tariff classification. From which source can the required classification be obtained?

✓ CHIEF

• CHEEF

• CHEAF

Q51: Brokers are allowed to broker pharmaceutical products which do not have a Marketing Authorisation (MA).

• True

✓ False

Q52: Broker registration requires you to have an RP.

• True

✓ False

Introduction to Auditing

Quiz: Introduction to Auditing: Pre-Training Test

Q1: What is the purpose of auditing or self-inspection?

✓ To check compliance with the specified requirements (EU Guidelines 2013/C 343/01)

• To assess personnel

• To ensure that training is effective

Q2: What chapter of the EU Guidelines (2013/C 343/01) covers self-inspection?

• Chapter 2

• Chapter 5

✓ Chapter 8

• Chapter 1

Q3: What does PDCA stand for?

✓ Plan, Do, Check, Act

• Plan, Do, Corrective Actions

• Plan, Do, Correct, Act

Q4: Select two reasons why we might audit a supplier against GDP.

✓ Before beginning trade with them

• If they have a new RP

✓ If a failure to perform has been flagged up

• If there has been a recall

Q5: Select three areas of focus when carrying out an audit.

✓ Documentation

✓ Processes/procedures

• Goods in/out

✓ Personnel

• Storage areas

Q6: Who would carry out a second party audit of a UK wholesaler?

✓ A customer

• The MHRA

• ISO

• A supplier

Q7: Who would carry out a third party audit for a UK wholesaler?

• ISO

• A customer

✓ The Competent Authority of the country (e.g. MHRA or HPRA)

• The IAG

Q8: What might you look for in an evidence-based audit of a goods in area? Select three options.

✓ If it is protected from harsh weather conditions

✓ If there is pest control

• The process of receiving goods

✓ If staff have had appropriate, documented training

• How staff are informed about goods that are due in

Q9: Select two examples of questions you might ask during a process-based audit?

• Show me a deviation report.

✓ Show me how you process a customer order.

✓ How do purchasing inform the warehouse that goods are due?

• Can you show me your complaints records?

Q10: Select two examples of transformational activities.

• Filling in a report

✓ Picking and packing of goods

✓ Receipt and processing of goods

• Asking questions to personnel

Q11: Should an auditor be looking for non-compliance?

• Yes

✓ No

Q12: What are the three classifications of deficiency? Answers can be entered in any order.

• 1. {} 2. {} 3. {}

Q13: Against which two documents should you reference any deficiencies?

• ICH Q9 2011

✓ EU Guidelines 2013/C 343/01

• Falsified Medicines Directive 2011

✓ Human Medicines Regulation 2012

Q14: What is the purpose of a closing meeting?

• To close out any deficiencies

✓ To give a verbal summary of the findings from the audit

Q15: Who can carry out a first party audit in a GDP site, as per the EU Guidelines (2013/C 343/01)? Select two.

• The RP's Deputy

✓ The RP

• Senior Management

✓ Anyone with suitable training

Q16: How often should a self-inspection happen at a GDP site, as minimum?

• Every 6 months

✓ Annually

• Every 18 months

• Every 9 months

Q17: How should you close out deficiencies found in your self-inspections?

• Plan and carry out an effective c{orrective} a{} ensuring that you look at the i{mpact} on all areas of operation.

Quiz: Introduction to Auditing

Q1: What is the purpose of auditing or self-inspection?

• To assess personnel

✓ To check compliance with the specified requirements (EU Guidelines 2013/C 343/01)

• To ensure that training is effective

Q2: What chapter of the EU Guidelines covers self-inspections?

• Chapter 5

• Chapter 1

✓ Chapter 8

• Chapter 2

Q3: What does PDCA stand for?

• Plan, Do, Corrective Actions

• Plan, Do, Correct, Act

✓ Plan, Do, Check, Act

Q4: Select two reasons why we might audit a supplier against GDP.

• If they have a new RP

✓ If a failure to perform has been flagged up

• If there has been a recall

✓ Before beginning trade with them

Q5: Select three areas of focus when carrying out an audit.

• Goods in/out

✓ Documentation

✓ Personnel

• Storage areas

✓ Processes/procedures

Q6: Who would carry out a second party audit of a UK wholesaler?

• A supplier

• ISO

✓ A customer

• The MHRA

Q7: Who would carry out a third party audit on a UK wholesaler?

✓ The Competent Authority of the country (e.g. the MHRA or HPRA)

• A customer

• The IAG

• ISO

Q8: What might you look for in an evidence-based audit of a goods in area. Select three options.

• The process of receiving goods

✓ If staff have had appropriate, documented training

✓ If it is protected from harsh weather conditions

• How staff are informed about goods that are due in

✓ If there is pest control

Q9: Select two examples of questions you might ask during a process-based audit?

✓ Show me how you process a customer order.

✓ How do purchasing inform the warehouse that goods are due?

• Show me a deviation report.

• Can you show me your complaints records?

Q10: Select two examples of transformational activities.

✓ Picking and packing of goods

✓ Receipt and processing of goods

• Filling in a report

• Asking questions to personnel

Q11: Should an auditor be looking for non-compliance?

✓ No

• Yes

Q12: What are the three classifications of deficiency? Answers can be entered in any order.

• 1. {} 2. {} 3. {}

Q13: Against which two documents should you reference any deficiencies?

• Falsified Medicines Directive 2011

✓ Human Medicines Regulation 2012

✓ EU Guidelines 2013/C 343/01

• ICH Q9 2011

Q14: What is the purpose of the closing meeting?

✓ To give a verbal summary of the findings from the audit

• To close out deficiencies

Q15: Who can carry out a first party audit in a GDP site, as per the EU Guidelines (2013/C 343/01)? Select two.

✓ The RP

• Senior Management

✓ Anyone with suitable training

• The RP's Deputy

Q16: How often should a self-inspection take place at a GDP site, at minimum?

• Every 9 months

• Every 6 months

• Every 18 months

✓ Annually

Q17: How should you close out deficiencies found in your self-inspections?

• Plan and carry out an effective c{ } a{ } ensuring that you look at the i{ } on all areas of operation.

Introduction to Pharmacovigilance in Good Distribution Practice

Quiz: Introduction to Pharmacovigilance in Good Distribution Practice Pre-test

Q1: Why are wholesalers and distributors included in Pharmacovigilance audits and inspections?

• They are outside the MAH’s system

✓ They are part of the MAH’s Pharmacovigilance system and their responsibilities must be verified

• They manufacture medicines

• They only handle logistics

Q2: What is the purpose of reconciliations between an MAH and a distributor?

✓ To verify all safety reports sent and received match

• To increase sales

• To schedule product recalls

• To train staff

Q3: Which activity is least likely to generate safety data impacting a wholesaler?

✓ Literature screening

• Controlled distribution programmes

• Patient support services

• Direct contact with healthcare professionals

Q4: What kind of agreement may be required if a wholesaler acts as an own-label supplier?

• Standard supply agreement

✓ Separate Pharmacovigilance Agreement (PVA)

• Loan agreement

• Employment contract

Q5: What is the main objective of Periodic Safety Update Reports (PSURs)?

✓ To evaluate the ongoing risk-benefit balance of a medicinal product

• To update packaging design

• To review manufacturing costs

• To provide financial reports to shareholders

Q6: What is a Dear Healthcare Professional Communication (DHPC) typically used for?

• Announcing new product launches

✓ Communicating important new safety information to prescribers

• Marketing purposes

• Conducting audits

Q7: Which document must list all business partners, PV service providers, and wholesalers/distributors?

• Patient Information Leaflet

✓ Pharmacovigilance System Master File (PSMF)

• Marketing Authorisation Application

• Periodic Safety Update Report

Q8: What is the purpose of literature screening in Pharmacovigilance?

• To monitor manufacturing processes

✓ To collect safety information from published literature

• To recruit new patients

• To advertise new medicine

Q9: What is a Patient Support Program (PSP) designed to do?

• Increase the price of medicines

✓ Help patients access treatment and manage their condition

• Replace healthcare professionals

• Restrict the use of medicines

Q10: Which of the following is NOT typically included in routine Risk Minimisation Measures (rRMMs)?

• Summary of Product Characteristics

• Patient Information Leaflet

✓ Controlled distribution programmes

• Legal status of the medicine

Q11: According to the guidelines, how soon should a wholesaler report any safety-related information to the MAH?

• Within one month

✓ Within one business day

• Immediately after the quarterly review

• Within one week

Q12: What is the role of Good Distribution Practice (GDP) in Pharmacovigilance?

• Focusing solely on pre-marketing surveillance

✓ Ensuring safety information is reported during the post-marketing stage

• Managing clinical trial data

• Authorising marketing applications

Q13: Which regulatory document mandates that all MAHs in the EU must have a sufficient Pharmacovigilance system?

✓ Directive 2001/83/EC

• The Human Medicines Regulations 2012

• The National Health Service Act

• The Good Clinical Practice Directive

Q14: What historical event highlighted the need for Pharmacovigilance?

• The polio vaccine introduction

✓ The death of Hannah Greener from a chloroform overdose

• Penicillin discovery

• The first heart transplant

Q15: What is the main ethical consideration in Pharmacovigilance?

• Reducing company costs

✓ Maximising benefits and minimising risks for patients

• Increasing market share

• Promoting over-the-counter sales

Q16: Which situation is categorised as a “special situation” in Pharmacovigilance?

✓ Use of a medicinal product during pregnancy or breastfeeding

• Standard prescription use

• Routine patient follow-up

• Manufacturing inspections

Q17: An Adverse Drug Reaction (ADR) is characterised by:

• A response with an unclear relationship to the medicine

✓ A noxious and unintended response where a causal relationship is at least a reasonable possibility

• A positive therapeutic outcome

• Any medical error

Q18: Which of the following best describes an Adverse Event (AE)?

• Always caused by the medicinal product

✓ Any untoward medical occurrence, not necessarily causally related to the treatment

• Only serious incidents are included

• Only laboratory findings are included

Q19: According to the WHO, Pharmacovigilance encompasses which of the following activities?

• Marketing strategies

✓ Detection, assessment, understanding, and prevention of adverse effects

• Manufacturing processes

• Legal prosecution of pharmaceutical companies

Q20: What is the primary aim of Pharmacovigilance under EU law?

• To promote new medicines

✓ To prevent harm from adverse reactions and promote safe and effective medicine use

• To reduce healthcare costs

• To conduct clinical trials

Quiz: Introduction to Pharmacovigilance in Good Distribution Practice Post-test

Q1: Why are wholesalers and distributors included in Pharmacovigilance audits and inspections?

• They are outside the MAH’s system

✓ They are part of the MAH’s Pharmacovigilance system and their responsibilities must be verified

• They manufacture medicines

• They only handle logistics

Q2: What is the purpose of reconciliations between an MAH and a distributor?

✓ To verify all safety reports sent and received match

• To increase sales

• To schedule product recalls

• To train staff

Q3: Which activity is least likely to generate safety data impacting a wholesaler?

✓ Literature screening

• Controlled distribution programmes

• Patient support services

• Direct contact with healthcare professionals

Q4: What kind of agreement may be required if a wholesaler acts as an own-label supplier?

• Standard supply agreement

✓ Separate Pharmacovigilance Agreement (PVA)

• Loan agreement

• Employment contract

Q5: What is the main objective of Periodic Safety Update Reports (PSURs)?

✓ To evaluate the ongoing risk-benefit balance of a medicinal product

• To update packaging design

• To review manufacturing costs

• To provide financial reports to shareholders

Q6: What is a Dear Healthcare Professional Communication (DHPC) typically used for?

• Announcing new product launches

✓ Communicating important new safety information to prescribers

• Marketing purposes

• Conducting audits

Q7: Which document must list all business partners, PV service providers, and wholesalers/distributors?

• Patient Information Leaflet

✓ Pharmacovigilance System Master File (PSMF)

• Marketing Authorisation Application

• Periodic Safety Update Report

Q8: What is the purpose of literature screening in Pharmacovigilance?

• To monitor manufacturing processes

✓ To collect safety information from published literature

• To recruit new patients

• To advertise new medicine

Q9: What is a Patient Support Program (PSP) designed to do?

• Increase the price of medicines

✓ Help patients access treatment and manage their condition

• Replace healthcare professionals

• Restrict the use of medicines

Q10: Which of the following is NOT typically included in routine Risk Minimisation Measures (rRMMs)?

• Summary of Product Characteristics

• Patient Information Leaflet

✓ Controlled distribution programmes

• Legal status of the medicine

Q11: According to the guidelines, how soon should a wholesaler report any safety-related information to the MAH?

• Within one month

✓ Within one business day

• Immediately after the quarterly review

• Within one week

Q12: What is the role of Good Distribution Practice (GDP) in Pharmacovigilance?

• Focusing solely on pre-marketing surveillance

✓ Ensuring safety information is reported during the post-marketing stage

• Managing clinical trial data

• Authorising marketing applications

Q13: Which regulatory document mandates that all MAHs in the EU must have a sufficient Pharmacovigilance system?

✓ Directive 2001/83/EC

• The Human Medicines Regulations 2012

• The National Health Service Act

• The Good Clinical Practice Directive

Q14: What historical event highlighted the need for Pharmacovigilance?

• The polio vaccine introduction

✓ The death of Hannah Greener from a chloroform overdose

• Penicillin discovery

• The first heart transplant

Q15: What is the main ethical consideration in Pharmacovigilance?

• Reducing company costs

✓ Maximising benefits and minimising risks for patients

• Increasing market share

• Promoting over-the-counter sales

Q16: Which situation is categorised as a “special situation” in Pharmacovigilance?

✓ Use of a medicinal product during pregnancy or breastfeeding

• Standard prescription use

• Routine patient follow-up

• Manufacturing inspections

Q17: An Adverse Drug Reaction (ADR) is characterised by:

• A response with an unclear relationship to the medicine

✓ A noxious and unintended response where a causal relationship is at least a reasonable possibility

• A positive therapeutic outcome

• Any medical error

Q18: Which of the following best describes an Adverse Event (AE)?

• Always caused by the medicinal product

✓ Any untoward medical occurrence, not necessarily causally related to the treatment

• Only serious incidents are included

• Only laboratory findings are included

Q19: According to the WHO, Pharmacovigilance encompasses which of the following activities?

• Marketing strategies

✓ Detection, assessment, understanding, and prevention of adverse effects

• Manufacturing processes

• Legal prosecution of pharmaceutical companies

Q20: What is the primary aim of Pharmacovigilance under EU law?

• To promote new medicines

✓ To prevent harm from adverse reactions and promote safe and effective medicine use

• To reduce healthcare costs

• To conduct clinical trials

Medical Devices Awareness Training

Quiz: Medical Devices Training Pre-Test

Q1: ISO certification does not mean automatic regulatory clearance for your products, because it is not a ________.

• License | 1 Lisence | 1 Licence | 1

Q2: What is the “Deming Cycle” also known as?

• Plan, Do, Check Action

• Plot, Document, Check, Authorise

✓ Plan, Do, Check, Act

• Plan, Draw, Check, Allocate

Q3: You own a company, and you are planning to manufacture medical devices. What certification will you require?

• ISO 9001:2015

✓ ISO13485

• ICH Q9

• WDA

Q4: According to W. F. Deming the American Industrialist, if you do not know what you are doing, what is it that you cannot describe?

• Product

• Price

✓ Process

• Your Job

Q5: In relation to the Quality Management System and the products, an organisation should plan and implement four processes. Name one of them.

Q6: Organizations often rush product development through in order to release it into the UK Market as soon as possible to maximise market presence and returns. What is often overlooked when this happens?

✓ Planning Phase

• Lunch Breaks

• Advertising

• Product Registration

Q7: There are factors of responsible resourcing that the management must engage with, in order to meet major regulatory and customer requirements. Select three genuine provisions from the list below:

✓ The supply of resources

• Cheapest packaging providers

✓ Contamination Control

• Fast Turnaround of orders

✓ Infrastructure

• Lowest Market Prices

Q8: Management must review a list of inputs to compare current performance with quality objectives. How many inputs as a minimum does ISO13485 require?

• 3

• 6

✓ 12

• 20

Q9: What does ISO13485 emphasise that you document? Name 1 factor.

• decisions | 1 records | 1 outputs | 1 output | 1

Q10: Who should be able to provide evidence of commitment to the development and maintenance of the QMS and it’s effectiveness?

• The Staff

• The License Holder

• The Auditors

✓ The Management

Q11: What kind of approach to the control of the appropriate processes is needed for a good QMS?

• Time-efficient

✓ Risk-based

• Thorough

Q12: To be certified to ISO13485, what must a company implement and maintain?

• quality management system | 1 qms | 1 a quality management system | 1 a qms | 1

Q13: Name 1 of the key elements of ISO13485.

Q14: ISO13485 addresses the specific needs of the Medical Device Industry. Which other ISO is it based upon?

• 9001:

2015

✓ 9001:

2008

• 9000:

1998

• 9002:

2012

Q15: Name a high-risk class 3 medical device.

Q16: If a medical device ‘category’ is determined by it’s use and application, what is its ‘class’ determined by?

• Weight

• Potency

• Cost

✓ Risk

Q17: Some devices contain a medical substance (or an Active Pharmaceutical Ingredient). True or False?

✓ True

• False

Q18: How many medical devices are there in the UK market?

• Aprox 300,000

• Less than 100,000

✓ Over 600,000

• 500,000

Q19: Name 1 way by which a medical device does NOT achieve its main intended action.

• Pharmacological | 1 immunological | 1 metabolic | 1

Q20: Who is responsible for ensuring the quality and safety of medical devices that are in the UK market?

• The UK Government

• GPhC

✓ MHRA

• The Home Office

Quiz: Medical Devices Training Post Test

Q1: ISO certification does not mean automatic regulatory clearance for your products, because it is not a ________.

• License | 1 Lisence | 1 Licence | 1

Q2: What is the “Deming Cycle” also known as?

• Plan, Do, Check Action

• Plot, Document, Check, Authorise

✓ Plan, Do, Check, Act

• Plan, Draw, Check, Allocate

Q3: You own a company, and you are planning to manufacture medical devices. What certification will you require?

• ISO 9001:2015

✓ ISO13485

• ICH Q9

• WDA

Q4: According to W. F. Deming the American Industrialist, if you do not know what you are doing, what is it that you cannot describe?

• Product

• Price

✓ Process

• Your Job

Q5: In relation to the Quality Management System and the products, an organisation should plan and implement four processes. Name one of them.

✓ Planning Phase

• Lunch Breaks

• Advertising

• Product Registration

✓ The supply of resources

• Cheapest packaging providers

✓ Contamination Control

• Fast Turnaround of orders

✓ Infrastructure

• Lowest Market Prices

Q8: Management must review a list of inputs to compare current performance with quality objectives. How many inputs as a minimum does ISO13485 require?

• 3

• 6

✓ 12

• 20

Q9: What does ISO13485 emphasise that you document? Name 1 factor.

• decisions | 1 records | 1 outputs | 1 output | 1

Q10: Who should be able to provide evidence of commitment to the development and maintenance of the QMS and it’s effectiveness?

• The Staff

• The License Holder

• The Auditors

✓ The Management

Q11: What kind of approach to the control of the appropriate processes is needed for a good QMS?

• Time-efficient

✓ Risk-based

• Thorough

Q12: To be certified to ISO13485, what must a company implement and maintain?

• quality management system | 1 qms | 1 a quality management system | 1 a qms | 1

Q13: Name 1 of the key elements of ISO13485.

Q14: ISO13485 addresses the specific needs of the Medical Device Industry. Which other ISO is it based upon?

• 9001:

2015

✓ 9001:

2008

• 9000:

1998

• 9002:

2012

Q15: Name a high-risk class 3 medical device.

Q16: If a medical device ‘category’ is determined by it’s use and application, what is its ‘class’ determined by?

• Weight

• Potency

• Cost

✓ Risk

Q17: Some devices contain a medical substance (or an Active Pharmaceutical Ingredient). True or False?

✓ True

• False

Q18: How many medical devices are there in the UK market?

• Aprox 300,000

• Less than 100,000

✓ Over 600,000

• 500,000

Q19: Name 1 way by which a medical device does NOT achieve its main intended action.

• Pharmacological | 1 immunological | 1 metabolic | 1

Q20: Who is responsible for ensuring the quality and safety of medical devices that are in the UK market?

• The UK Government

• GPhC

✓ MHRA

• The Home Office

Non-Conformance And Deviation Management (GDP)

Quiz: Pre-Test: Deviations

Q1: What is a deviation?

• A planned permanent change to a procedure or established standard.

• An action that needs to be reported.

• An action that corrects an identified problem or incident.

✓ A departure from an approved instruction or established standard.

Q2: How are deviations classified?

✓ Deviations are classified according to the impact and risk to product quality or patient safety.

• Deviations are classified according to management without support from Quality Assurance (QA).

• Deviations are classified based on the type of product being distributed.

• Deviations are classified depending on how urgent the product is needed by the customer.

Q3: How would you classify the following deviation:

Rejected product accidentally released to market which has the potential to cause significant risk to patient safety.

• Major

✓ Critical

• Minor

Q4: Why do we need to manage deviations?

✓ Regulatory requirement to ensure satisfactory product quality (fit for purpose) and patient safety.

• To ensure personnel that are apart of the deviation, or the cause, are held responsible.

• So management can discipline personnel and team members.

• To make permanent planned changes within a company and to keep a record of change.

Q5: What is typically included in the "Description" of a deviation investigation?

• Failure Modes and Effect Analysis

• Root Cause Analysis

✓ Who, What, When, Where and How the incident or event happened with evidence (e.g. photographs, videos, samples, witness statements, etc.)

• Corrective and Preventive Actions (CAPAs)

Q6: What is the purpose of writing the "Description" of a deviation?

✓ To identify what should have happened that didn't happen with adequate evidence and a record of events.

• To identify the root cause of the incident or event.

• To create a false timeline of events and create a fictitious story of what happened.

• To describe the department or personnel responsible and assign blame.

Q7: What are the Five W's?

• 1 = { } 2 = { } 3 = { } 4 = { } 5 = { }

Q8: Why is it important to classify a deviation?

• So it can be assigned to the right personnel.

✓ So it can be progressed urgently and prioritised.

• It helps identify the root cause.

• It helps assign CAPA(s).

Q9: What is a Containment Action or Correction?

✓ These refer to actions performed immediately at the time of the incident.

• These are CAPA(s) used to resolve the root cause.

• This is part of the Scope Assessment.

• This is a part of Quality Risk Management.

Q10: Why is performing a "Scope Assessment" important?

✓ To enable a decision to be made with regards to the impact of all products, processes or systems potentially impacted.

• To reject products and materials.

• To terminate systems and procedures that are disliked.

• To stay in compliance with company procedures and policy.

Q11: Which areas are covered under an "Impact Assessment"?

✓ Product quality

✓ Patient safety

✓ Quality Management System (QMS)

✓ Good Distribution Practice (GDP)

• Root Cause Analysis

• CAPA Assessment

Q12: Why is it important to identify product impact?

• Helps with Trend Analysis

✓ Assists in determining whether a product is fit for purpose.

• Enables Root Cause Analysis

• So CAPA(s) can be implemented.

Q13: A significant temperature excursion occurs during product distribution. Is this considered a deviation?

✓ Yes

• No

• Possibly

Q14: An incident has occurred in which a violation of a Quality Technical Agreement (QTA) has happened. Should this be assessed in the impact assessment?

• No

• Possibly

✓ Yes

Q15: Products have been delivered to the incorrect recipient. Is this a deviation?

✓ Yes

• No

Q16: Should regulatory implications be assessed as part of the deviation Impact Assessment?

✓ Yes

• No

Q17: What is "Risk Analysis" within an Impact Assessment?

• A process to review complaints.

• A process to review financial risk management for a business or company.

✓ A process to review the risks to the quality of pharmaceutical products or systems.

• A process to review patient health risks.

Q18: What criterion is "Risk Analysis" scored against?

✓ Severity

• Strength

• Impact

• Root Cause

Q19: How would you classify a risk to patient safety, product quality or regulatory compliance?

• Medium

✓ High

• Low

• None

Q20: What is Root Cause Analysis?

✓ Identifying the underlying problem of an incident or event.

• Symptomatic issue of an event or incident.

• The description of an incident or event.

• The action taken to correct an identified problem.

Q21: What is likely to happen if the root cause is not accurately identified?

• The QMS will be continuously improved.

✓ There will be an increase in repeat occurrences.

• There will be a decrease in repeat occurrences.

• There will be an increase in product quality and patient safety.

Q22: Which of the below are Root Cause Analysis tools?

✓ 5 Why's

• Quality Risk Management

• Scope Assessment

✓ Fishbone (Ishikawa) Diagram

Q23: What is a Fishbone analysis diagram?

✓ A diagram form of brainstorming.

• A process flow diagram.

• A diagram form of asking 5 Why's

• An organogram

Q24: When should the Root Cause Analysis be performed?

• Before the Impact Assessment

✓ After the Impact Assessment

• After the Description of the event or incident

• After establishing CAPA(s)

Q25: What is the meaning of CAPA?

• C{} A{} P{} A{}

Q26: What is the purpose of a CAPA?

✓ Resolve the identified root cause and prevent recurrence.

• Identify the level of risk from the event or incident.

• Describe a timeline of events of the deviation.

• Review historical deviations to identify any trends.

Q27: Do all Corrective Actions have an associated Preventive Action?

• Yes

✓ No

Q28: Preventive Actions focus on resolving the root cause of a current incident or problem?

• True

✓ False

Q29: What is an Effectiveness Check?

• Defined parameters to verify how quickly deviations are closed.

• Defined parameters to verify how accurate the Impact Assessment is.

✓ Defined parameters to verify how successful a CAPA is.

• Defined parameters to verify how accurate the root cause is.

Quiz: Good Distribution Practice: Deviations

Q1: What is a deviation?

• A planned permanent change to a procedure or established standard.

• An action that needs to be reported.

• An action that corrects an identified problem or incident.

✓ A departure from an approved instruction or established standard.

Q2: How are deviations classified?

✓ Deviations are classified according to the impact and risk to product quality or patient safety.

• Deviations are classified according to management without support from Quality Assurance (QA).

• Deviations are classified based on the type of product being distributed.

• Deviations are classified depending on how urgent the product is needed by the customer.

Q3: How would you classify the following deviation:

Rejected product accidentally released to market which has the potential to cause significant risk to patient safety.

• Major

✓ Critical

• Minor

Q4: Why do we need to manage deviations?

✓ Regulatory requirement to ensure satisfactory product quality (fit for purpose) and patient safety.

• To ensure personnel that are apart of the deviation, or the cause, are held responsible.

• So management can discipline personnel and team members.

• To make permanent planned charges within a company and to keep a record of change.

Q5: What is typically included in the "Description" of a deviation investigation?

• Failures Modes and Effect Analysis

• Root Cause Analysis

✓ Who, What, When, Where and How the incident or event happened with evidence (e.g. photographs, videos, samples, witness statements, etc.)

• Corrective and Preventive Actions (CAPAs)

Q6: What is the purpose of writing the "Description" of a deviation?

• To identify the root cause of the incident or event.

✓ To identify what should have happened that didn't happen with adequate evidence and a record of events.

• To create a false timeline of events and create a fictitious story of what happened.

• To describe the department or personnel responsible and assign blame.

Q7: What are the 5 W's?

• 1 = { } 2 = { } 3 = { } 4 = { } 5 = { }

Q8: Why is it important to classify a deviation?

• So it can be assigned to the right personnel.

✓ So it can be progressed urgently and prioritised.

• It helps identify the root cause.

• It helps assign the CAPA(s).

Q9: What is a Containment Action or Correction?

✓ These refer to actions performed immediately at the time of the incident.

• These are CAPA(s) used to resolve the root cause.

• This is part of the Scope Assessment.

• This is a part of the Quality Risk Management.

Q10: Why is performing a "Scope Assessment" important?

• To reject products and materials.

• To terminate systems and procedures that are disliked.

• To stay in compliance with company procedures and policy.

✓ To enable a decision to be made with regards to the impact of all products, processes or systems potentially impacted.

Q11: Which areas are covered under an "Impact Assessment"?

✓ Product Quality

✓ Patient Safety

✓ Quality Management System (QMS)

✓ Good Distribution Practice (GDP)

• Root Cause Analysis

• CAPA Assessment

Q12: Why is it important to identify product impact?

• Helps with Trend Analysis

✓ Assists in determining whether a product is for purpose.

• Enables Root Cause Analysis

• So CAPA(s) can be implemented.

Q13: A significant temperature excursion occurs during product distribution. Is this considered a deviation?

✓ Yes

• No

• Possibly

Q14: An incident has occurred in which a violation of a Quality Technical Agreement (QTA) has happened. Should this be assessed in the impact assessment?

• No

• Possibly

✓ Yes

Q15: Products have been delivered to the incorrect recipient. Is this a deviation?

✓ Yes

• No

Q16: Should regulatory implications be assessed as part of the deviation Impact Assessment?

✓ Yes

• No

Q17: What is "Risk Analysis" within an Impact Assessment?

• A process to review complaints.

• A process to review financial risk management for a business or company.

✓ A process to review the risks to the quality of pharmaceutical products or systems.

• A process to review patient health risks.

Q18: What criterion is "Risk Analysis" scored against?

✓ Severity

• Strength

• Impact

• Root Cause

Q19: How would you classify a risk to patient safety, product quality or regulatory compliance?

• Medium

✓ High

• Low

• None

Q20: What is Root Cause Analysis?

✓ Identifying the underlying problem of an incident or event.

• Symptomatic issue of an event or incident.

• The description of an incident or event.

• The action taken to correct an identified problem.

Q21: What is likely to happen if the root cause is not accurately identified?

• The QMS will be continuously improved.

✓ There will be an increase in repeat occurrences.

• There will be a decrease in repeat occurrences.

• There will be an increase in product quality and patient safety.

Q22: Which of the below are Root Cause Analysis tools?

✓ 5 Why's

• Quality Risk Management

• Scope Assessment

✓ Fishbone (Ishikawa) Diagram

Q23: What is a Fishbone analysis diagram?

✓ A diagram form of brainstorming.

• A process flow diagram.

• A diagram form of asking the 5 Why's

• An organogram.

Q24: When should the Root Cause Analysis be performed?

• Before the Impact Assessment

✓ After the Impact Assessment

• After the Description of the event or incident

• After establishing CAPA(s)

Q25: What is the meaning of CAPA?

• C{} A{} P{} A{}

Q26: What is the purpose of a CAPA?

✓ Resolve the identified root cause and prevent recurrence.

• Identify the level of risk from the event or incident.

• Describe a timeline of events of the deviation.

• Review historical deviations to identify any trends.

Q27: Do all Corrective Actions have an associated Preventive Action?

• Yes

✓ No

Q28: Preventive Actions focus on resolving the root cause of a current incident or problem?

• True

✓ False

Q29: What is an Effectiveness Check?

• Defined parameters to verify how quickly deviations are closed.

• Defined parameters to verify how accurate the Impact Assessment is.

✓ Defined parameters to verify how successful a CAPA is.

• Defined parameters to verify how accurate the root cause is.

Online GDP Webinar – GDP for RPs and Management

Quiz: GDP for RPs and Management – Pre Test

Q1: As stated in EU Guidelines 2013/C 343/01 the quality system is the responsibility of the organisation’s ……………………………… and requires their leadership and active participation?

Q2: What 4 letter principle relating to product expiry dates should goods be stored under, and what does each of the letters mean?

Q3: When organising transport without temperature control, what should be in place ahead of shipping product. 1 point.

Q4: Name 4 of the 5 things that should be covered in a management review.

Q5: How do you qualify a UK pharmacy?

Q6: Can a licensed broker procure and supply medicines?

Q7: Explain why there is a requirement for adequate separation between receipt, dispatch and storage areas.

Q8: Name two ways to approve/bona fide an EU wholesale supplier.

Q9: What Guideline of the International Conference of Harmonisation (ICH) covers Quality Risk Management?

Q10: According to the official definition of a falsified medicinal product, how can a product be considered falsified? (1 point per answer, up to 3 points.)

Q11: For how long must GDP records be retained?

Q12: What do the letters “CAPA” stand for?

Q13: How would you segregate similar pharmaceutical product types held in the storage areas of the warehouse, to reduce the risk of picking errors?

Q14: Define a “Correction” and a “Corrective Action”.

Q15: Name six of the twelve responsibilities of the Responsible Person as per EU Guidance 2013/C 343/01?

Q16: Who can recommend a change to the QMS?

Q17: According to EU GDP 2013/C 343/01 when should staff have training?

Q18: Give the two main reasons why goods MUST be stored off the floor?

Q19: Suggest two occasions when staff should be re-trained?

Q20: What is the name of the MHRA website for reporting fake and/or faulty medicines, devices, and adverse reactions?

Q21: What would you do in the event of a temperature excursion/deviation in your fridge or ambient storage? Pick and state which one. (1 point per comment, up to 4 points.)

Q22: How long do you have to complete a Class 2 Recall?

Q23: EU Guidance 2013/C 343/01 states that receiving and dispatch bays should offer protection from what?

Q24: What are the two classifications of complaint in GDP?

Q25: According to EU guidance 2013/C 343/01 in relation to employee’s possessions; what four things should specifically be prohibited in the storage areas of the wholesaler?

Q26: Who must be the final arbitrator of complaints in GDP?

Q27: Suggest some important things you should check when receiving a delivery. 1 point per correct answer, up to 4 points

Q28: What is the role of the MHRA “DMRC” and what do each of the letters mean?

Q29: What is the acceptable temperature range for cold chain products?

Q30: Chapter 7 (Outsourced Activities), requires a contract for outsourced GDP activities. Give four examples of outsourced activities that may require a contract. (1 point each answer, up to 4 points.)

Q31: Name two circumstances when you should you re-map a fridge?

Q32: What is the purpose of a self-inspection, as per Chapter 8?

Q33: Please write the definition for each of the below acronyms:

1. GDP= 2. SOP = 3. WDA = 4. QMS = 5. MHRA = 6. RP =

Q34: How many suitable temperature reference points should your thermometer/logger/system ideally be calibrated to?

Q35: What is the maximum time in hours that a transit point can hold goods without having their own WDA? a. Ambient:

b. Chilled:

Quiz: GDP For RPs and Management – Post test

Q1: Explain why there is a requirement for adequate separation between receipt, dispatch and storage areas.

Q2: Name two ways to approve/bona fide an EU wholesale supplier?

Q3: What Guideline of the International Conference of Harmonisation (ICH) covers Quality Risk Management?

Q4: According to the official definition of falsified medicinal products; How can a product be considered falsified? (1 point per answer, up to 3 points.)

Q5: For how long must GDP records be retained?

Q6: What do the letters “CAPA” stand for?

Q7: How would you segregate similar pharmaceutical product types held in the storage areas of the warehouse, to reduce the risk of picking errors?

Q8: Define a “Correction” and a “Corrective Action”.

Q9: Name six of the twelve responsibilities of the Responsible Person, as per EU Guidance 2013/C 343/01?

Q10: Who can recommend a change to the QMS?

Q11: According to EU Guidance 2013/C 343/01, when should staff receive GDP training?

Q12: Give the two main reasons why goods MUST be stored off the floor?

Q13: Suggest two occasions when staff should be re-trained?

Q14: What is the name of the MHRA website for reporting fake and faulty medicines, devices, and adverse reactions?

Q15: What would you do in the event of a temperature excursion/deviation in your fridge or ambient storage? (Pick and state which one). (1 point per comment, up to 4 points.)

Q16: How long do you have to complete a Class 2 Recall?

Q17: EU Guidance 2013/C 343/01 states that receiving and dispatch bays should offer protection from what?

Q18: What are the two classifications of complaint in GDP?

Q19: According to EU guidance 2013/C 343/01 in relation to employee’s possessions; what four things should specifically be prohibited in the storage areas of the wholesaler?

Q20: Who must be the final arbitrator of complaints in GDP?

Q21: Suggest some important things you should check when receiving a delivery. 2 correct answers for 4 points.

Q22: What is the role of the DMRC and what do each of the letters mean?

Q23: What is the acceptable temperature range for cold chain products?

Q24: Chapter 7 (Outsourced Activities), requires a contract for outsourced GDP activities. Give four examples of outsourced activities that may require a contract. (1 point each answer, up to 4 points.)

Q25: Name two circumstances when you should you re-map a fridge?

Q26: What is the purpose of a self-inspection, as per Chapter 8?

Q27: Please write the definition for each of the below acronyms:

1. GDP= 2. SOP = 3. WDA = 4. QMS = 5. MHRA = 6. RP =

Q28: How many suitable temperature reference points should your thermometer/logger/system ideally be calibrated to?

Q29: What is the maximum time in hours that a transit point can hold goods without having their own WDA? 1 point for two correct answers. a. Ambient:

b. Chilled:

Q30: As stated in EU Guidelines 2013/C 343/01, the quality system is the responsibility of the organisation’s ……………………………… and requires their leadership and active participation.

Q31: What 4 letter principle relating to product expiry dates should goods be stored under, and what does each of the letters mean?

Q32: When organising transport without temperature control, what should be in place ahead of shipping product. 1 point.

Q33: Name 4 of the 5 things that should be covered in a management review.

Q34: How do you qualify a UK pharmacy?

Q35: Can a licensed broker procure and supply medicines?

Outsourced Activities and Responsibilities of the Licence Holder and Responsible Person

Quiz: Outsourced Activities and Responsibilities of the LH and RP – Pre Test

Q1: When were the Human Medicines Regulations last updated?

• 2010

• 2011

✓ 2012

• 2013

Q2: Complete the following statement:

The Human Medicines Regulations require that the licence holder ensures the "provision of suitable _______, premises, equipment and facilities".

• Customers

✓ Staff

• Suppliers

• Managers

Q3: An Article 126a Authorisation permits a medicinal product, that does not have a marketing authorisation, to be placed on the market under what circumstances?

• Financial reasons

• Convenience

✓ Justified public health reasons

Q4: Complete the following statement:

"The quality system is the responsibility of the organisation's _________ and requires their leadership and active participation."

• Warehouse Department

• Responsible Person

✓ Management

• Staff

• Finance Department

Q5: The expectation of the Human Medicines Regulation is that if an RP is not a pharmacist or QP, they should have at least three years relevant practical and managerial experience of medicinal products.

• True

✓ False

Q6: What does QP stand for?

• Quality Personnel

• Qualified Pharmacist

✓ Qualified Person

Q7: Which of the below activities should the RP carry out themselves (i.e. not delegate)?

• Ensuring that a quality management system is implemented and maintained.

✓ Acting as a management representative.

✓ Focusing on the management of authorised activities and the accuracy and quality of records.

• Ensuring that initial and continuous training programmes are implemented and maintained.

• Ensuring that relevant customer complaints are dealt with effectively and in a timely manner.

• Ensuring that suppliers and customers are approved.

✓ Coordinating and promptly performing any recall operations for medicinal products.

Q8: Which of the following should a pharmaceutical wholesaler's Quality Manual contain?

✓ Company Details

✓ Organisation Chart

• Temperature Mapping Reports

• Staff Training Records

✓ Key Performance Indicators

Q9: What is meant by KPI?

✓ Key Performance Indicator

• Key Practice Identifier

• Key Process Information

Q10: Choose three elements of the GDP quality system that can be used as KPIs.

• Temperature Mapping

✓ Feedback on Outsourced Activities

✓ Complaints

✓ Deviations

• Temperature Monitoring

Q11: An interim review of an SOP relating to GDP activities is required after which of the following?

✓ Legislation changes

• A company pay rise

✓ Operational changes within the business

✓ Staffing changes

• Changes to the company's pension scheme

✓ Significant events or incidents

Q12: Complete the following statement:

"Risk-based thinking provides the opportunity to put into place ________ controls to minimise negative impacts and to make maximum use of any opportunities that may present themselves."

• Reactive

✓ Preventive

• Proactive

Q13: GDP requires that the evaluation of risk to quality should be based on 'scientific knowledge', what is meant by that in this context?

• Knowledge of scientific processes

✓ Experience with the process

Q14: Choose the correct wording combination from the options below to complete the following statement:

" Working to identify new risks (both internal and external) ensures that your QMS becomes _______ rather than _______."

✓ Proactive, Reactive

• Reactive, Proactive

• Active, Inactive

Q15: What two parties are involved in 'Outsourced Actvities'?

✓ Contract Giver

• Contract Provider

✓ Contract Acceptor

• Contract Receiver

Q16: What should be in place between the two parties involved in outsourced activities?

• A Licensing Agreement

• A Transport Agreement

✓ A Technical Agreement

Q17: Control of Outsourced Activities should incorporate quality risk management principles that require which of the following to be carried out?

✓ Assessing the suitability and competence of the contract acceptor to carry out the activity and checking authorisation when required.

✓ Defining the responsibilities and communication processes for the quality related activities of the parties involved.

✓ Monitoring and review of the performance of the contract acceptor and the identification and implementation of required improvements on a regular basis.

Q18: Complete the following statement:

"________ responsibilities, within the technical/quality agreement, should be avoided as this can lead to them being missed as each party thinks that the other is carrying out that activity."

• Individual

✓ Shared

• Multiple

• Singular

Q19: Chapter 1.4 of the GDP EU Guidelines documents the requirement for which of the following?

✓ Management Review and Monitoring

• The Quality System

• Outsourced Activities

• Quality Risk Management

Q20: Management review meeting minutes must be which of the following?

✓ Documented in a timely manner

• Restricted to those present at the meeting

✓ Retained for at least five years

✓ Acted upon in a suitable time-frame

Q21: Audits of companies undertaking outsourced activities can be used as KPIs in the management review process.

✓ True

• False

Q22: The Licence Holder and RP are responsible for all activities contracted out and all services which might be sub-contracted out by the service provider.

✓ True

• False

Q23: Which ICH Guideline is referred to in Chapter 1.5 of the EU GDP Guidelines?

• ICH Q7

• ICH Q8

✓ ICH Q9

• ICH Q10

Q24: Quality Risk Management is:

"A systematic process for the assessment, control, communication and review of risks to the quality of medicinal product."

✓ True

• False

Quiz: Outsourced Activities and Responsibilities of the LH and RP – Post Test

Q1: When were the Human Medicines Regulations last updated?

✓ 2012

• 2010

• 2013

• 2011

Q2: Complete the following statement:

The Human Medicines Regulations require that the licence holder ensures the "provision of suitable _______, premises, equipment and facilities".

• Customers

• Managers

• Suppliers

✓ Staff

Q3: An Article 126a Authorisation permits a medicinal product, that does not have a marketing authorisation, to be placed on the market under what circumstances?

• Convenience

✓ Justified public health reasons

• Financial reasons

Q4: Complete the following statement:

"The quality system is the responsibility of the organisation's _________ and requires their leadership and active participation."

✓ Management

• Finance Department

• Warehouse Department

• Staff

• Responsible Person

Q5: The expectation of the Human Medicines Regulation is that if an RP is not a pharmacist or QP, he/she should have at least three years relevant practical and managerial experience of medicinal products.

• True

✓ False

Q6: What does QP stand for?

• Quality Personnel

✓ Qualified Person

• Qualified Pharmacist

Q7: Which of the below activities should the RP carry out themselves (i.e. not delegate)?

✓ Acting as a management representative.

• Ensuring that a quality management system is implemented and maintained.

✓ Focusing on the management of authorised activities and the accuracy and quality of records.

• Ensuring that initial and continuous training programmes are implemented and maintained.

• Ensuring that relevant customer complaints are dealt with effectively and in a timely manner.

✓ Coordinating and promptly performing any recall operations for medicinal products.

• Ensuring that suppliers and customers are approved.

Q8: Which of the following should a pharmaceutical wholesaler's Quality Manual contain?

• Staff Training Records

✓ Company Details

✓ Organisation Chart

• Temperature Mapping Reports

✓ Key Performance Indicators

Q9: What is meant by KPI?

✓ Key Performance Indicator

• Key Practice Identifier

• Key Process Information

Q10: Choose three elements of the GDP quality system that can be used as KPIs.

✓ Feedback on Outsourced Activities

• Temperature Mapping

• Temperature Monitoring

✓ Deviations

✓ Complaints

Q11: An interim review of an SOP relating to GDP activities is required after which of the following:

• A company pay rise

✓ Legislation changes

✓ Operational changes within the business

✓ Significant events or incidents

✓ Staffing changes

• Changes to the company's pension scheme

✓ Preventive

• Proactive

• Reactive

Q13: GDP requires that the evaluation of risk to quality should be based on 'scientific knowledge', what is meant by that in this context?

✓ Experience with the process

• Knowledge of the scientific processes

• Reactive, Proactive

• Active, Inactive

✓ Proactive, Reactive

Q15: What two parties are involved in 'Outsourced Actvities'?

• Contract Provider

• Contract Receiver

✓ Contract Giver

✓ Contract Acceptor

Q16: What should be in place between the two parties involved in outsourced activities?

✓ A Technical Agreement

• A Transport Agreement

• A Licensing Agreement

Q17: Control of Outsourced Activities should incorporate quality risk management principles that require which of the following to be carried out?

✓ Assessing the suitability and competence of the contract acceptor to carry out the activity and checking authorisation when required.

✓ Defining the responsibilities and communication processes for the quality related activities of the parties involved.

✓ Monitoring and review of the performance of the contract acceptor and the identification and implementation of required improvements on a regular basis.

• Multiple

• Individual

• Singular

✓ Shared

Q19: Chapter 1.4 of the GDP EU Guidelines documents the requirement for which of the following?

• The Quality System

• Quality Risk Management

✓ Management Review and Monitoring

• Outsourced Activities

Q20: Management review meeting minutes must be which of the following?

✓ Retained for at least five years

✓ Acted upon in a suitable time-frame

• Restricted to those present at the meeting

✓ Documented in a timely manner

Q21: Audits of companies undertaking outsourced activities can be used as KPIs in the management review process.

✓ True

• False

Q22: The Licence Holder and RP are responsible for all activities contracted out and all services which might be sub-contracted out by the service provider.

✓ True

• False

Q23: Which ICH Guideline is referred to in Chapter 1.5 of the EU GDP Guidelines?

• ICH Q7

✓ ICH Q9

• ICH Q8

• ICH Q10

Q24: Quality Risk Management is:

"A systematic process for the assessment, control, communication and review of risks to the quality of medicinal product."

✓ True

• False

Pest Control Training

Quiz: PEST CONTROL TRAINING – POST TEST

Q1: Who must sign off the data entry into the pest control records logbook once completed?

• Yourself

✓ The RP

• The Manager

Q2: How many Risk Classifications are there?

• 5

• 4

✓ 3

• 2

Q3: An inspector has recorded a critical failure against your licence for failing to manage pest activity in your premises. Who is going to know about it?

• Just You

• You and The Inspector

✓ The Wider Public

• You and the Staff

• The Management will keep it quiet

Q4: True or False:

“The cost of stock that has been damaged/contaminated by pest activity must be charged to the supplier”.

• True

✓ False

Q5: Which two items must never be placed into waste bins within or near the storage areas?

• Used PPE

✓ Food Waste

• Plastic Bags

✓ Food and Drink Containers

• Spent Wrapping Film

Q6: Who is responsible for overseeing that the building is fit for purpose and suitable for the storage of medicinal products?

• The Manager

✓ The Licence Holder

• The QA Person

• The Staff

Q7: In one word, what ‘V’ is NOT a sufficient contractual agreement?

• verbal | 1

Q8: Who needs to approve and sign all contracts with third party providers?

• Yourself

✓ The RP

• The Manager

• The MHRA

Q9: Apart from Licenses, Companies House checks and references, what other public body can recommend or offer an approved pest control service?

• Local Refuse Collection Service

• Local Vet Shop

✓ The Local Council

• Police Dept

Q10: Before any Pest Control Provider could offer a service consistent with your Quality Management System, who must they be approved by?

• PCBA

✓ BPCA

• ABPA

• CAPB

Q11: You discover where pests may be getting into the premises, but do not know where they are going to. What approved device or method might you use to find out?

• Sticky Board

✓ Tracking Dust

• traps

Q12: You discover some products contaminated by pest activity. To which dedicated area should they be moved?

• Near the loading bay

✓ Quarantine Area

• Any clear space in the storage area

Q13: You discover a nest with eggs high up in the corner of the warehouse which is apparently occupied by a rare bird. Select the correct course of action.

• Destroy the nest and keep the eggs

• Call a local pet shop

• Call a local bird sanctuary

✓ Consult a pest control professional

• Carefully move the nest outside

Q14: Select four approved and permitted pest control devices or systems.

• Fly Spray

✓ Rat Traps

✓ Sticky Boards

• Fly Swatters

✓ Mouse Boxes

✓ Moth Traps

Q15: Failure to deal with the pest ingress on your site also means you are failing to observe the required Health and Safety Regulations. Select the three penalties that would apply.

• A Caution

✓ 6 month prison sentence

✓ £20,000 fine

• Community Service

• £250 fine

✓ Potential Closure of Site

Q16: An MHRA inspector can mark failure to deal with pests in one of three classifications, depending on the severity. Identify the three classifications.

• Minor (or other)

• small

• Critical

✓ Major

• Acceptable

• Catastrophic

Q17: What contamination could be present on goods that would render them unsellable and unsafe?

• urine | 1 pee | 1 poo | 1 droppings | 1 faeces | 1 excrement | 1

Q18: What should you wear when checking and searching for pests/evidence of pests?

• Protective Headgear

✓ Gloves

• Breathing Apparatus

• Toe-capped Boots

Q19: A rat or mouse that has died can generate a huge number of maggots if not found and disposed of responsibly. What do these maggots ultimately become?

• Worms

• Caterpillars

✓ Flies

• Spiders

Q20: What national organisation does your contracted Pest Control Service Provider have to be registered and approved by? (State full name).

• The Local Council

✓ British Pest Control Association

• The Police

• The National Veterinary Association

Q21: The Health and Safety At Work Act makes sure that your personnel have a safe environment to work in. What year was it published?

• 1947

• 1794

✓ 1974

• 1977

Q22: Which chapter of the EU GDP Guidelines speaks about Pest Control regimes?

• 6

• 2

✓ 3

• 7

Q23: Name 3 types of insects (not species) that are pests.

✓ Flying

• Swimming

✓ Crawling

✓ Biting

• Creeping

• Burrowing

Q24: In business terms, what are pests that can infest, damage and contaminate a site otherwise known as?

• A Nuisance

• Wildlife

✓ Vermin

• An inconvenience

Quiz: PEST CONTROL TRAINING – PRE TEST

Q1: Who must sign off the data entry into the pest control records logbook once completed?

• Yourself

✓ The RP

• The Manager

Q2: How many Risk Classifications are there?

• 5

• 4

✓ 3

• 2

Q3: An inspector has recorded a critical failure against your licence for failing to manage pest activity in your premises. Who is going to know about it?

• Just You

• You and The Inspector

✓ The Wider Public

• You and the Staff

• The Management will keep it quiet

Q4: True or False:

“The cost of stock that has been damaged/contaminated by pest activity must be charged to the supplier”.

• True

✓ False

Q5: Which two items must never be placed into waste bins within or near the storage areas?

• Used PPE

✓ Food Waste

• Plastic Bags

✓ Food and Drink Containers

• Spent Wrapping Film

Q6: Who is responsible for overseeing that the building is fit for purpose and suitable for the storage of medicinal products?

• The Manager

✓ The Licence Holder

• The QA Person

• The Staff

Q7: In one word, what ‘V’ is NOT a sufficient contractual agreement?

• verbal | 1

Q8: Who needs to approve and sign all contracts with third party providers?

• Yourself

✓ The RP

• The Manager

• The MHRA

Q9: Apart from Licenses, Companies House checks and references, what other public body can recommend or offer an approved pest control service?

• Local Refuse Collection Service

• Local Vet Shop

✓ The Local Council

• Police Dept

Q10: Before any Pest Control Provider could offer a service consistent with your Quality Management System, who must they be approved by?

• PCBA

✓ BPCA

• ABPA

• CAPB

Q11: You discover where pests may be getting into the premises, but do not know where they are going to. What approved device or method might you use to find out?

• Sticky Board

✓ Tracking Dust

• traps

Q12: You discover some products contaminated by pest activity. To which dedicated area should they be moved?

• Near the loading bay

✓ Quarantine Area

• Any clear space in the storage area

Q13: You discover a nest with eggs high up in the corner of the warehouse which is apparently occupied by a rare bird. Select the correct course of action.

• Destroy the nest and keep the eggs

• Call a local pet shop

• Call a local bird sanctuary

✓ Consult a pest control professional

• Carefully move the nest outside

Q14: Select four approved and permitted pest control devices or systems.

• Fly Spray

✓ Rat Traps

✓ Sticky Boards

• Fly Swatters

✓ Mouse Boxes

✓ Moth Traps

Q15: Failure to deal with the pest ingress on your site also means you are failing to observe the required Health and Safety Regulations. Select the three penalties that would apply.

• A Caution

✓ 6 month prison sentence

✓ £20,000 fine

• Community Service

• £250 fine

✓ Potential Closure of Site

Q16: An MHRA inspector can mark failure to deal with pests in one of three classifications, depending on the severity. Identify the three classifications.

• Minor (or other)

• small

• Critical

✓ Major

• Acceptable

• Catastrophic

Q17: What contamination could be present on goods that would render them unsellable and unsafe?

• urine | 1 pee | 1 poo | 1 droppings | 1 faeces | 1 excrement | 1

Q18: What should you wear when checking and searching for pests/evidence of pests?

• Protective Headgear

✓ Gloves

• Breathing Apparatus

• Toe-capped Boots

Q19: A rat or mouse that has died can generate a huge number of maggots if not found and disposed of responsibly. What do these maggots ultimately become?

• Worms

• Caterpillars

✓ Flies

• Spiders

Q20: What national organisation does your contracted Pest Control Service Provider have to be registered and approved by? (State full name).

• The Local Council

✓ British Pest Control Association

• The Police

• The National Veterinary Association

Q21: The Health and Safety At Work Act makes sure that your personnel have a safe environment to work in. What year was it published?

• 1947

• 1794

✓ 1974

• 1977

Q22: Which chapter of the EU GDP Guidelines speaks about Pest Control regimes?

• 6

• 2

✓ 3

• 7

Q23: Name 3 types of insects (not species) that are pests.

✓ Flying

• Swimming

✓ Crawling

✓ Biting

• Creeping

• Burrowing

Q24: In business terms, what are pests that can infest, damage and contaminate a site otherwise known as?

• A Nuisance

• Wildlife

✓ Vermin

• An inconvenience

Responsible Person for import (RPi)

Quiz: RPi TRAINING COURSE Post Test

Q1: “Importation of products without a marketing authorisation in the UK, Northern Ireland, Great Britain, or a listed country, are permitted under the supervision of a Responsible Person (RP)”. True or False?

✓ True

• False

Q2: Select two acceptable equivalent qualifications for RPi candidates:

• A GCSE Level Pass in Biology

✓ Level 5 qualifications from Chartered Institute of Logistics and Transport

• A City and Gilds in Chemistry

✓ A QMS Lead Auditor Qualification

• A Health and Safety at Work Certification issued by the HSE

Q3: If you source a medicine for Great Britain with a ‘(UA)’ suffix, where are you only permitted to purchase it from? (Two answers).

• Any Country within the EEA

✓ A Northern Ireland Manufacturer or Wholesaler (qualified business)

• Only Countries where batches are checked by relevant QPs

• A Wholesaler or Manufacturer in Southern Ireland

✓ A wholesale dealer in Great Britain

Q4: What additional regulation to the Human Medicines Regulations 2012 specifies eligibility of an individual to act as Responsible Person for import?

✓ Regulation 45-AB

• Regulation 54-A

• Regulation 44-BB

Q5: Which EudraLex Volume of the EU Good Manufacturing Practice, provides guidance on QP certification for EU manufactured products for human use?

• Volume 1

• Volume 7

✓ Volume 4

Q6: A new proposal was drafted to amend UK Human Medicines Regulations 2012 due to UK withdrawal from the European Union (Regulations 2019 No.775:

Exiting the European Union). What was the draft based upon?

✓ A Potential “No Deal” Scenario

• A Possible Review of Transportation Requirements

• The likelihood of the Prime Minister losing his tenure at no10.

Q7: Who ultimately determines the suitability of an RPi candidate, based on the candidate’s experience of the proposed licence activity?

• The Home Office

• The Company’s contracted GDP Consultancy

✓ The Licensing Authority (MHRA)

Q8: Who is eligible to act as an RPi, subject to providing evidence of qualifications and membership of a professional body, and registration on the appropriate database?

✓ UK Qualified Persons

• The Company CEO

• The Shipping and Transportation Supervisor

Q9: Some product licence numbers are suffixed with “UA”. What does “UA” stand for?

• Unilateral Access

✓ Unfettered Access

• Universal Access

Q10: When do you need a Responsible Person (RP) and not a Responsible Person for Import (RPi)?

• If the Medicinal Product is licensed in the UK but not the listed country

✓ If the medicinal product is neither licensed in the UK or the listed country

• If the medicinal product is not licensed in the UK as well as the listed country

Q11: What must the License Holder apply for when importing controlled substances (CDs)?

✓ Import License permission from the Home Office

• Import License permission from the MHRA

• Police permission for importation of CDs.

Q12: Who or what, became the stand-alone National Control Laboratory on the 1st January 2021?

• The Medicines and Healthcare products Regulatory Agency

• The General Pharmaceutical Council

✓ The National Institute for Biological Standards and Control

Q13: “Nominating a Responsible Person for Import to undertake specific functions (on all WDA license variations), is a voluntary requirement”. True or False?

✓ False

• True

Q14: What does Regulation 45-AB specify an eligible individual to act as?

• A Quality Control Person

• A Subject Matter Expert

✓ A Responsible Person for Import

Q15: Select the three missing acronyms from this statement:

“I hereby certify that all the manufacturing stages of this batch of finished product have been carried out in full compliance with the ___ requirements of the ___ and with the requirements of the ___ of the destination country/countries.”

• QMS

• RA

✓ GMP

• GDP

✓ EU

• EEA

✓ MA

• MHRA

Q16: Who must certify every batch of medicinal products in the listed country of the supplier, before the goods are exported to the UK?

✓ The QP (Qualified Person)

• The Transport/Shipping Supervisor

• The Packing Team

Q17: The Human Medicines Regulations 2019 Amendment came into force on “exit day”. What date was this?

• 1st January 2020

✓ 31st January 2020

• Midnight 31st December 2019

Q18: Where importing Narcotic and Psychotropic substances are concerned, what must the License Holder do?

• Contract a high security company to transport it

✓ Apply to the Home Office for import license permission

• Apply for special clearance from the shipping port / airport authority

Q19: What does the import of Unlicensed Medicines continue to require?

• Permission from the UK Home Office

• Copies of the Import Documents sent to the Metropolitan Police for clearance

✓ Notification to the MHRA Unlicensed Imports Team

Q20: Pack Security Measures are usually serial barcodes and tamper-evident seals. What are Italian and Greek labels known as?

✓ Bollino and Nom labels

• Bolero and Non labels

• Bollardo and Moni labels

Q21: If the RPi is found not to be following the requirements, who can remove them as RPi and report them to their professional body?

• A Second Party Auditor

• The Wholesale Company Management

✓ The Inspection Action Group

• A Customer's Management

Quiz: RPi TRAINING COURSE Pre Test

✓ True

• False

Q2: Select two acceptable equivalent qualifications for RPi candidates:

• A GCSE Level Pass in Biology

✓ Level 5 qualifications from Chartered Institute of Logistics and Transport

• A City and Gilds in Chemistry

✓ A QMS Lead Auditor Qualification

• A Health and Safety at Work Certification issued by the HSE

Q3: If you source a medicine for Great Britain with a ‘(UA)’ suffix, where are you only permitted to purchase it from? (Two answers).

• Any Country within the EEA

✓ A Northern Ireland Manufacturer or Wholesaler (qualified business)

• Only Countries where batches are checked by relevant QPs

• A Wholesaler or Manufacturer in Southern Ireland

✓ A wholesale dealer in Great Britain

Q4: What additional regulation to the Human Medicines Regulations 2012 specifies eligibility of an individual to act as Responsible Person for import?

✓ Regulation 45-AB

• Regulation 54-A

• Regulation 44-BB

Q5: Which EudraLex Volume of the EU Good Manufacturing Practice, provides guidance on QP certification for EU manufactured products for human use?

• Volume 1

• Volume 7

✓ Volume 4

✓ A Potential “No Deal” Scenario

• A Possible Review of Transportation Requirements

• The likelihood of the Prime Minister losing his tenure at no10.

Q7: Who ultimately determines the suitability of an RPi candidate, based on the candidate’s experience of the proposed licence activity?

• The Home Office

• The Company’s contracted GDP Consultancy

✓ The Licensing Authority (MHRA)

Q8: Who is eligible to act as an RPi, subject to providing evidence of qualifications and membership of a professional body, and registration on the appropriate database?

✓ UK Qualified Persons

• The Company CEO

• The Shipping and Transportation Supervisor

Q9: Some product licence numbers are suffixed with “UA”. What does “UA” stand for?

• Unilateral Access

✓ Unfettered Access

• Universal Access

Q10: When do you need a Responsible Person (RP) and not a Responsible Person for Import (RPi)?

• If the Medicinal Product is licensed in the UK but not the listed country

✓ If the medicinal product is neither licensed in the UK or the listed country

• If the medicinal product is not licensed in the UK as well as the listed country

Q11: What must the License Holder apply for when importing controlled substances (CDs)?

✓ Import License permission from the Home Office

• Import License permission from the MHRA

• Police permission for importation of CDs.

Q12: Who or what, became the stand-alone National Control Laboratory on the 1st January 2021?

• The Medicines and Healthcare products Regulatory Agency

• The General Pharmaceutical Council

✓ The National Institute for Biological Standards and Control

Q13: “Nominating a Responsible Person for Import to undertake specific functions (on all WDA license variations), is a voluntary requirement”. True or False?

✓ False

• True

Q14: What does Regulation 45-AB specify an eligible individual to act as?

• A Quality Control Person

• A Subject Matter Expert

✓ A Responsible Person for Import

• QMS

• RA

✓ GMP

• GDP

✓ EU

• EEA

✓ MA

• MHRA

Q16: Who must certify every batch of medicinal products in the listed country of the supplier, before the goods are exported to the UK?

✓ The QP (Qualified Person)

• The Transport/Shipping Supervisor

• The Packing Team

Q17: The Human Medicines Regulations 2019 Amendment came into force on “exit day”. What date was this?

• 1st January 2020

✓ 31st January 2020

• Midnight 31st December 2019

Q18: Where importing Narcotic and Psychotropic substances are concerned, what must the License Holder do?

• Contract a high security company to transport it

✓ Apply to the Home Office for import license permission

• Apply for special clearance from the shipping port / airport authority

Q19: What does the import of Unlicensed Medicines continue to require?

• Permission from the UK Home Office

• Copies of the Import Documents sent to the Metropolitan Police for clearance

✓ Notification to the MHRA Unlicensed Imports Team

Q20: Pack Security Measures are usually serial barcodes and tamper-evident seals. What are Italian and Greek labels known as?

✓ Bollino and Nom labels

• Bolero and Non labels

• Bollardo and Moni labels

Q21: If the RPi is found not to be following the requirements, who can remove them as RPi and report them to their professional body?

• A Second Party Auditor

• The Wholesale Company Management

✓ The Inspection Action Group

• A Customer's Management

Steve – Test Course

Quiz: Steve – Tester

Q1: What does the acronym “WDA” stand for? Select 2.

• Wholesale Drug handling Agency

• World Distribution Agency

✓ Wholesale Dealer Authorisation

✓ Wholesale Distribution Authorisation

The Global Supply Chain

Quiz: THE GLOBAL SUPPLY CHAIN – Pre test

Q1: What additional security accreditation can you look for in a haulier?

• TALA-PSR

✓ TAPA-TSR

• TASA-FCR

Q2: What temperature management solution can be used to briefly prevent aircraft loading/unloading excursions?

• Foam pellets

• Cardboard

✓ Thermal covers

Q3: At what temperature must pharmaceuticals products be transported?

✓ The temperature according to the outer product packaging

• 15-25°C

• 2-25°C

Q4: What does "CRT" stand for?

• Controlled Room Transport

• Controlled Risk Transport

✓ Controlled Room Temperature

• Controlled Risk Temperature

Q5: "Security is the highest risk factor for road distribution". True or False?

✓ True

• False

Q6: What can be used to maintain the temperature within an Ocean shipping container?

✓ Genset

• Tempset

• Celset

Q7: During the Ocean cargo process, who sub-contracts the haulier?

• The forwarder

• The shipper

✓ The ocean carrier

Q8: Which stage of air transportation has the highest risk of temperature excursions?

✓ Aircraft loading

• Delivery to the GHA

• Cross-docking

Q9: During the Air cargo process, who sub-contracts the GHA (Ground Handling Agents)?

• The forwarder

✓ The Air Carrier

• The Shipper

Q10: When shipping Dangerous Goods, an MSDS sheet must travel alongside the cargo. What does MSDS stand for?

• Material Substance Data Sheet

✓ Material Safety Data Sheet

• Material Safety Documented Standards

Q11: What mode of transport does IATA regulate?

✓ Air

• Sea

• Road

Q12: "Air Cargo has the highest risk of theft and tampering." True or False?

• True

✓ False

Q13: Which one of the following are Incoterms only used for sea and inland waterway?

• Ex-Works

• Carriage Insurance Paid To

✓ Free on Board

Q14: Which Incoterm shouldn’t be used when shipping pharmaceuticals?

• Delivered Duty Paid (DDP)

✓ EX Works (EXW)

• Delivered at Place Unloaded (DPU)

Q15: What does the Incoterm "DAP" stand for?

• Delivered at Port

• Delivered at Premises

✓ Delivered at Place

Q16: What does "INCO" stand for in the word IncoTerms?

✓ International Commercial Terms

• International Shipping Terms

• In-transit Control Terms

Q17: Who is responsible for ‘classifying’ the goods and providing the commodity code?

✓ The shipper

• HMRC

• The Freight Forwarder

Q18: Who is responsible for ensuring the product is approved in the country of export?

• The Freight Forwarder

✓ The shipper

• HMRC

Q19: What is the first thing you’ll need prior to exporting?

• Commercial Invoice

• Packing list

✓ EORI number

Q20: What is the most efficient method of identifying risks throughout your supply chain?

• CAPA action plan

✓ Route risk assessments

• Self-Inspections

Quiz: THE GLOBAL SUPPLY CHAIN – Post Test

Q1: Which stage of air transportation has the highest risk of temperature excursions?

✓ Aircraft loading

• Delivery to the GHA

• Cross-docking

Q2: During the Ocean cargo process, who sub-contracts the haulier?

• The forwarder

• The shipper

✓ The ocean carrier

Q3: What can be used to maintain the temperature within an Ocean shipping container?

✓ Genset

• Tempset

• Celset

Q4: "Security is the highest risk factor for road distribution". True or False?

✓ True

• False

Q5: What is the most efficient method of identifying risks throughout your supply chain?

• CAPA action plan

✓ Route risk assessments

• Self-Inspections

Q6: What does "CRT" stand for?

• Controlled Room Transport

• Controlled Risk Transport

✓ Controlled Room Temperature

• Controlled Risk Temperature

Q7: What is the first thing you’ll need prior to exporting?

• Commercial Invoice

• Packing list

✓ EORI number

Q8: At what temperature must pharmaceuticals products be transported?

✓ The temperature according to the outer product packaging

• 15-25°C

• 2-25°C

Q9: Who is responsible for ensuring the product is approved in the country of export?

• The Freight Forwarder

✓ The shipper

• HMRC

Q10: What temperature management solution can be used to briefly prevent aircraft loading/unloading excursions?

• Foam pellets

• Cardboard

✓ Thermal covers

Q11: Who is responsible for ‘classifying’ the goods and providing the commodity code?

✓ The shipper

• HMRC

• The Freight Forwarder

Q12: What additional security accreditation can you look for in a haulier?

• TALA-PSR

✓ TAPA-TSR

• TASA-FCR

Q13: What does "INCO" stand for in the word IncoTerms?

✓ International Commercial Terms

• International Shipping Terms

• In-transit Control Terms

Q14: What does the Incoterm "DAP" stand for?

• Delivered at Port

• Delivered at Premises

✓ Delivered at Place

Q15: Which Incoterm shouldn’t be used when shipping pharmaceuticals?

• Delivered Duty Paid (DDP)

✓ EX Works (EXW)

• Delivered at Place Unloaded (DPU)

Q16: Which one of the following are Incoterms only used for sea and inland waterway?

• Ex-Works

• Carriage Insurance Paid To

✓ Free on Board

Q17: "Air Cargo has the highest risk of theft and tampering." True or False?

• True

✓ False

Q18: What mode of transport does IATA regulate?

✓ Air

• Sea

• Road

Q19: When shipping Dangerous Goods, an MSDS sheet must travel alongside the cargo. What does MSDS stand for?

• Material Substance Data Sheet

✓ Material Safety Data Sheet

• Material Safety Documented Standards

Q20: During the Air cargo process, who sub-contracts the GHA (Ground Handling Agents)?

• The forwarder

✓ The Air Carrier

• The Shipper

Unlicensed Medicines

Quiz: UNLICENCED MEDICINES: PRE-TEST Module

Q1: The aim of Good Manufacturing Practice (GMP) is:

• 1. Create consistency of product quality batch to batch.

• 2. Increase regulation to deter new companies from starting.

• 3. Ensure staff have a framework of guidance to work to when manufacturing medicines.

• 4. Answer no1 only.

✓ 5. Answers no1 and no3 only.

Q2: If you want to manufacture unlicensed controlled drug medicines, which of the following licences do you require?

✓ MS and domestic controlled drug licence

• WDA (h) and a domestic controlled drug licence

• MS licence

• Active substance licence

Q3: The cost of poor quality is:

• A combination of visible and hidden costs

• Reputational damage

• Regulatory sanctions

✓ All of the above

Q4: Advertising rules are defined in:

• The Orange Guide

✓ The Blue Guide

• The Green Guide

Q5: Licence holders are responsible for:

• Ensuring the facilities are appropriate

• Staff employed are appropriate for their role

• Ensure key quality indicators are monitored

✓ All of the above

• No3 Only

Q6: Your customers include:

• Pharmacies

• Hospitals

• Supplement Health stores e.g; Holland and Barrett

✓ Pharmacies and Hospitals Only

Q7: How often should quality matrix be produced?

• Daily

• Weekly

✓ Monthly

• Annual only

Q8: What are the minimum quality parameters to include in quality matrix?

✓ Complaints, deviations and Environmental Monitoring

• Deviations, change controls and self-inspections

• Staff disciplinary reports

Q9: As a senior leader...

• You are not expected to be available for regulatory inspections

✓ You should have a good understanding of the day to day operations and quality indicators

• You can delegate all your accountability to team members

Q10: Senior Management must ensure:

• All staff have regular GMP training

• All new staff have an induction to GMP performed

• Ensure staff are trained for their role and deemed competent

• Ensure teams are resourced correctly

✓ All of the above

Q11: Suppliers should be:

• Approved by QA prior to use.

• Periodically checked by QA to ensure initial approval is still valid.

• Maintained in a list so checks can be made by Finance and Purchasing.

✓ All of the above.

Q12: The consequences of poor supplier relationships include:

• Supply of stock ceased.

• Delay in supply of product to customers.

• Regulatory action.

✓ All of the above.

Q13: 1.Pharmacy customers can be approved by:

✓ Checking their GPhC Premises number.

• Checking the MHRA list of wholesale dealers.

• Checking their website.

Q14: Order placing:

• Should be in writing by the manufacturer

✓ Should be in writing from the customer

• Can be in any format

Q15: Unlicensed medicines can only be supplied if:

• 1:

There is a clinical need, defined by the prescriber.

• 2:

There is no licensed equivalent medicine available.

• 3:

If the product is cheaper than what is already on the market.

✓ 1 and 2 only.

Q16: If a licensed wholesaler wants to purchase a controlled drug, they require:

• WDA (h) only.

• MS and Domestic CD licence.

✓ WDA (h) and Domestic CD licence.

Q17: The grade of cleanroom required to manufacture non-sterile products is:

• A

• B

• C

✓ D

Q18: A cleanroom must be validated in the following areas:

• Particle count.

• Microbe counts.

• Pressure differentials.

✓ All of the above.

Q19: "All staff should have GMP training before they enter a GMP area."

✓ True.

• False.

Q20: Production staff should ensure:

• They check their materials are correct for the product.

• Equipment used is calibrated when applicable.

• Equipment is of a fit state of repair.

✓ All of the above.

Q21: "QA is the sum total of the organized arrangements, made with the objective of ensuring that medicinal products are of the quality required for their intended use."

✓ True.

• False.

Q22: An SOP should:

• Give staff the freedom to perform an activity as they see fit.

✓ Be version controlled, have an issue and effective date and the history of changes should be available in the QMS.

• The QMS system does not need to track changes to SOPs.

Q23: Quality trending should include:

✓ Deviations.

• Company profit statement.

• Competitor activities.

Q24: 'CAPA' stands for:

• Cancel all problems ASAP.

✓ Corrective Action Preventive Action.

• Correct Accident Prevent Accident.

Q25: “Raw Material Suppliers must ALL be EU GMP approved for unlicensed medicines.”

• True.

✓ False.

Q26: “As a minimum, the MHRA expect all APIs to have a full C of A analysis performed by the MS holder.”

• True.

✓ False.

Q27: Formulations of finished products must:

• Meet the needs of the prescriber instructions.

• Be approved by a suitably trained and experience staff member with at least 2 years’ experience.

• Discussed with the prescriber if materials available do not have the desired quality parameters.

✓ All of the above options.

Q28: “Unlicensed medicines all have an SPC and PIL.”

• True.

✓ False.

Q29: “A physical check of deliveries is not required as stock is always ordered from approved suppliers.”

• True.

✓ False.

Q30: “Counterfeit products are easy to identify.”

• True.

✓ False.

Q31: The warehouse management must include:

✓ Temperature monitoring.

✓ Pest Control.

✓ Appropriate stock locations.

• Suitable Refreshment Dispensing Facilities.

Q32: How can the despatch team ensure product quality is maintain during delivery?

✓ Ensure the product is packed in the appropriate validated packaging to maintain storage temperature.

• Ensure as many products are placed in the secondary packaging as possible to remove air pockets.

• Ensure the courier places products packed first on the van first.

Quiz: Unlicensed Medicines Post-test

Q1: The aim of Good Manufacturing Practice (GMP) is:

• 1. Create consistency of product quality batch to batch.

• 2. Increase regulation to deter new companies from starting.

• 3. Ensure staff have a framework of guidance to work to when manufacturing medicines.

• 4. Answer no1 only.

✓ 5. Answers no1 and no3 only.

Q2: If you want to manufacture unlicensed controlled drug medicines, which of the following licences do you require?

✓ MS and domestic controlled drug licence

• WDA (h) and a domestic controlled drug licence

• MS licence

• Active substance licence

Q3: The cost of poor quality is:

• A combination of visible and hidden costs

• Reputational damage

• Regulatory sanctions

✓ All of the above

Q4: Advertising rules are defined in:

• The Orange Guide

✓ The Blue Guide

• The Green Guide

Q5: Licence holders are responsible for:

• Ensuring the facilities are appropriate

• Staff employed are appropriate for their role

• Ensure key quality indicators are monitored

✓ All of the above

• No3 Only

Q6: Your customers include:

• Pharmacies

• Hospitals

• Supplement Health stores e.g; Holland and Barrett

✓ Pharmacies and Hospitals Only

Q7: How often should quality matrix be produced?

• Daily

• Weekly

✓ Monthly

• Annual only

Q8: What are the minimum quality parameters to include in quality matrix?

✓ Complaints, deviations and Environmental Monitoring

• Deviations, change controls and self-inspections

• Staff disciplinary reports

Q9: As a senior leader...

• You are not expected to be available for regulatory inspections

✓ You should have a good understanding of the day to day operations and quality indicators

• You can delegate all your accountability to team members

Q10: Senior Management must ensure:

• All staff have regular GMP training

• All new staff have an induction to GMP performed

• Ensure staff are trained for their role and deemed competent

• Ensure teams are resourced correctly

✓ All of the above

Q11: Suppliers should be:

• Approved by QA prior to use.

• Periodically checked by QA to ensure initial approval is still valid.

• Maintained in a list so checks can be made by Finance and Purchasing.

✓ All of the above.

Q12: The consequences of poor supplier relationships include:

• Supply of stock ceased.

• Delay in supply of product to customers.

• Regulatory action.

✓ All of the above.

Q13: 1.Pharmacy customers can be approved by:

✓ Checking their GPhC Premises number.

• Checking the MHRA list of wholesale dealers.

• Checking their website.

Q14: Order placing:

• Should be in writing by the manufacturer

✓ Should be in writing from the customer

• Can be in any format

Q15: Unlicensed medicines can only be supplied if:

• 1:

There is a clinical need, defined by the prescriber.

• 2:

There is no licensed equivalent medicine available.

• 3:

If the product is cheaper than what is already on the market.

✓ 1 and 2 only.

Q16: If a licensed wholesaler wants to purchase a controlled drug, they require:

• WDA (h) only.

• MS and Domestic CD licence.

✓ WDA (h) and Domestic CD licence.

Q17: The grade of cleanroom required to manufacture non-sterile products is:

• A

• B

• C

✓ D

Q18: A cleanroom must be validated in the following areas:

• Particle count.

• Microbe counts.

• Pressure differentials.

✓ All of the above.

Q19: "All staff should have GMP training before they enter a GMP area."

✓ True.

• False.

Q20: Production staff should ensure:

• They check their materials are correct for the product.

• Equipment used is calibrated when applicable.

• Equipment is of a fit state of repair.

✓ All of the above.

Q21: "QA is the sum total of the organized arrangements, made with the objective of ensuring that medicinal products are of the quality required for their intended use."

✓ True.

• False.

Q22: An SOP should:

• Give staff the freedom to perform an activity as they see fit.

✓ Be version controlled, have an issue and effective date and the history of changes should be available in the QMS.

• The QMS system does not need to track changes to SOPs.

Q23: Quality trending should include:

✓ Deviations.

• Company profit statement.

• Competitor activities.

Q24: 'CAPA' stands for:

• Cancel all problems ASAP.

✓ Corrective Action Preventive Action.

• Correct Accident Prevent Accident.

Q25: “Raw Material Suppliers must ALL be EU GMP approved for unlicensed medicines.”

• True.

✓ False.

Q26: “As a minimum, the MHRA expect all APIs to have a full C of A analysis performed by the MS holder.”

• True.

✓ False.

Q27: Formulations of finished products must:

• Meet the needs of the prescriber instructions.

• Be approved by a suitably trained and experience staff member with at least 2 years’ experience.

• Discussed with the prescriber if materials available do not have the desired quality parameters.

✓ All of the above options.

Q28: “Unlicensed medicines all have an SPC and PIL.”

• True.

✓ False.

Q29: “A physical check of deliveries is not required as stock is always ordered from approved suppliers.”

• True.

✓ False.

Q30: “Counterfeit products are easy to identify.”

• True.

✓ False.

Q31: The warehouse management must include:

✓ Temperature monitoring.

✓ Pest Control.

✓ Appropriate stock locations.

• Suitable Refreshment Dispensing Facilities.

Q32: How can the despatch team ensure product quality is maintain during delivery?

✓ Ensure the product is packed in the appropriate validated packaging to maintain storage temperature.

• Ensure as many products are placed in the secondary packaging as possible to remove air pockets.

• Ensure the courier places products packed first on the van first.

Warehouse Cleaning and Personnel

Quiz: Cleaning – Warehouse Personnel: Pre-Test

Q1: What can cause contamination? Select 3 answers.

✓ Water

✓ Pests

✓ Cleaning products

• Being near another medicinal product

Q2: Fill in the blanks.

• A pest is an {} or other {} that harms or destroys garden plants, trees, etc.

Q3: When will employees need training?

✓ Before taking up their job role and then at the regular intervals.

• During their probation period and then at regular intervals.

• Before taking up their job role and then every few years.

• Before taking up their job role and then only when there have been major issues or changes.

Q4: Who must you inform if you find any issues within the warehouse?

✓ The RP and Line Management

• The RP and Licence Holder

• Line Management

Q5: Fill in the blank

• What two documents must be included in the cleaning procedure? Cleaning {} Cleaning {}

Q6: How often should cleaning schedules be checked and signed off ?

• At least weekly

• At least daily

✓ At least monthly

• At least bi-monthly

Q7: Which dating format should you use on all documents to avoid confusion?

✓ 11 Oct 2021

• 11/10/21

Q8: Fill in the blank

• {Falsified} documentation can create serious {regulatory} issues, including the risk of {suspension} of the company's licence.

Q9: How can you ensure that products waiting for destruction do not re-enter the supply chain? 2 answers.

• Mark all the damaged medicine boxes with a marker pen

✓ Check the identification of the person collecting the waste

✓ Filing proof of collection

Q10: How long do all records need to be kept for?

• At least 3 years

✓ At least 5 years

• At least 7 years

• At least 10 years

Q11: Whose responsibility is it to keep the warehouse clean?

• The RP

• Warehouse Management

✓ All Warehouse Personnel

Q12: How long does coronavirus stay on the surfaces for?

• Up to 48 hours

✓ Up to 72 hours

• Up to 36 hours

• Up to 60 hours

Q13: Where should contaminated products be stored?

✓ Quarantine area

• Goods-Out area

• Waste area

• Destruction area

Q14: Fill in the blank

• Contamination is:

"Making something {} or {} by contact with something unclean, bad, etc."

Q15: What should not be taken into the warehouse?

✓ Food and drink

✓ Personal Medication

• Phones

✓ Personal smoking materials

• Electrical Devices

Q16: Can you use correction fluid/Tippex in your documents if a mistake is made?

• Yes

✓ No

Q17: "If problems are found during a self-inspection/ audit they should be recorded in a report and actions taken to fix them."

✓ True

• False

Q18: Fill in the blank

• If {} cleaning products are used, medicinal products stored in the area need to be {}

Q19: Fill in the blank

• Any products used for pest control purposes should not {} the medicinal products. Any products used for pest control purposes should not {[contaminate} the medicinal products.

Q20: Who needs to be informed if evidence of pests is found?

✓ The RP

• The Licence Holder

• Other Cleaners

• Warehouse Personnel

Q21: If moving medicinal products to a new area whilst cleaning you must ensure that the area is:

• In the same building

✓ Temperature-mapped

• A similar layout

• Away from other products

Q22: What item that if kept in the storage area can be useful for the RP and/or Supervisor?

• A chair

✓ Inventory Log Book

• Mobile Phone

Q23: What item can cause damage and injury if the container nozzle fails?

✓ Compressed Gas

• Oxidising Agent

• Hazard to Environment

Q24: Which symbol indicates that the product is highly toxic through inhalation, skin contact and ingestion?

• Test Tube and Hand

• Exclamation mark

✓ Skull and Crossbones

Q25: How many COSSH warning symbols are there?

• 11

• 7

✓ 9

• 12

Q26: What do all chemical cleaning products have on the containers by law?

• A brightly coloured cap

✓ A warning and information label

Quiz: Cleaning – Warehouse Personnel

Q1: What can cause contamination? Select 3 answers.

✓ Water

✓ Pests

✓ Cleaning products

• Being near another medicinal product

Q2: Fill in the blanks

• A pest is an {} or other {} that harms or destroys garden plants, trees, etc.

Q3: When will employees need training?

✓ Before taking up their job role and then at the regular intervals

• During their probation period and then at regular intervals

• Before taking up their job role and then every few years

• Before taking up their job role and then only when there have been major issues or changes

Q4: Who must you inform if you find any issues within the warehouse?

✓ The RP and Line Management

• The RP and Licence Holder

• Line Management

Q5: Fill in the blank

• Cleaning {} Cleaning {}

Q6: How often should cleaning schedules be checked and signed off ?

• At least weekly

• At least daily

✓ At least monthly

• At least bi-monthly

Q7: Which dating format should you use on all documents to avoid confusion?

✓ 11 Oct 2021

• 11/10/21

Q8: Fill in the blank

• {Falsified} documentation can create serious {regulatory} issues, including the risk of {suspension} of the company's licence.

Q9: How can you ensure that products waiting for destruction do not re-enter the supply chain? 2 answers.

• Mark all the damaged medicine boxes with a marker pen

✓ Check the identification of the person collecting the waste

✓ Filing proof of collection

Q10: How long do all records need to be kept for?

• At least 3 years

✓ At least 5 years

• At least 7 years

• At least 10 years

Q11: Who's responsibility is it to keep the warehouse clean?

• The RP

• Warehouse Management

✓ All Warehouse Personnel

Q12: How long does coronavirus stay on the surfaces for?

• Up to 48 hours

✓ Up to 72 hours

• Up to 36 hours

• Up to 60 hours

Q13: Where should contaminated products be stored?

✓ Quarantine area

• Goods-Out area

• Waste area

• Destruction area

Q14: Fill in the blank

• Contamination is:

"Making something {} or {} by contact with something unclean, bad, etc."

Q15: What should not be taken into the warehouse?

✓ Food and drink

✓ Personal Medication

• Phones

✓ Personal Smoking Materials

• Electrical Devices

Q16: Can you use correction fluid/Tippex in your documents if a mistake is made?

• Yes

✓ No

Q17: "If problems are found during a self-inspection/ audit they should be recorded in a report and actions taken to fix them."

✓ True

• False

Q18: Fill in the blank

• If {} cleaning products are used, medicinal products stored in the area need to be {}

Q19: Fill in the blank

• Any products used for pest control purposes should not {} the medicinal products. Any products used for pest control purposes should not {[contaminate} the medicinal products.

Q20: Who needs to be informed if evidence of pests is found?

✓ The RP

• The Licence Holder

• Other Cleaners

• Warehouse Personnel

Q21: If moving medicinal products to a new area whilst cleaning you must ensure that the area is:

• In the same building

✓ Temperature-mapped

• A similar layout

• Away from other products

Q22: What item that if kept in the storage area can be useful for the RP and/or Supervisor?

• A chair

✓ Inventory Log Book

• Mobile Phone

Q23: What item can cause damage and injury if the container nozzle fails?

✓ Compressed Gas

• Oxidising Agent

• Hazard to Environment

Q24: Which symbol indicates that the product is highly toxic through inhalation, skin contact and ingestion?

• Test Tube and Hand

• Exclamation mark

✓ Skull and Crossbones

Q25: How many COSSH warning symbols are there?

• 11

• 7

✓ 9

• 12

Q26: What do all chemical cleaning products have on the containers by law?

• A brightly coloured cap

✓ A warning and information label

Warehouse Operational GDP & Thermal Compliance

Quiz: Warehouse Operational GDP & Thermal Compliance PRE TEST

Q1: “It’s not written down as a procedure but you’ve done it anyway. As long as you tell the RP, this is acceptable”. True or False?

✓ False

• True

Q2: You see a fellow employee handling products who appears to be very ill. What do you do?

• Give them medicine

• Make them a coffee

✓ Report to line manager / RP

• Suggest they do a different task elsewhere

Q3: What four items are not permitted in the storage areas?

✓ Food

• Watches

✓ Drinks

✓ Smoking/Vaping material

✓ Personal Medication

• iPads

Q4: Which type of products MUST be given priority when unloading commences? Choose 3 options.

✓ Chilled

• Herbal Medicines

✓ Controlled Drugs

• Ambient Liquids

✓ Cytotoxic

Q5: What should be recorded when a delivery arrives? Choose 4 options.

✓ Your name

✓ Driver name / i.d

• Weight of the vehicle

✓ Date and time

✓ Registration of vehicle

• Weather conditions

Q6: Potential improvements to warehouse structure and procedures can be proposed through the Change Control process. Who is able to suggest these changes?

• The RP Only

• Management Only

✓ Anyone

• Licence Holder Only

Q7: In one word, what should the loading bay doors be when not in use?

• closed | 1 shut | 1

Q8: What is the acronym (initials) of the standard contract model that applies to goods being shipped internationally by road?

• CMR | 1 CMR Delivery Note | 1 Delivery note CMR | 1

Q9: What do the initials “MAWB” mean?

• Master Airway Bill | 1

Q10: What five words does the acronym “ALCOA” stand for? Name them in order.

• attributable legible contemporaneous original accurate | 1 attributable, legible, contemporaneous, original, accurate | 1

Q11: There are two main documents presented as National transport Documentation. One is a delivery note. What is the other?

✓ ASN
- advanced shipping notification

• BOL
- bill of lading

• MAWB
- master airway bill

Q12: What does “contemporaneous” mean?

• Data is recorded by another person who you give a verbal account to.

• Data is recorded at the end of the week

✓ Data is recorded at the same time as the event or action, or immediately afterward.

• Data is recorded in an ad-hoc casual manner

Q13: What do the initials “ASN” mean?

• Advance Shipping Notice | 1 Advanced Shipping Notice | 1 Advance Shipping Notification | 1 Advanced Shipping Notification | 1

Q14: What is the definition used within GDP of someone who is not deemed by the company as having rightful access to premises and restricted areas?

• unauthorised | 1 unauthorized | 1

Q15: "As long as precautions and risks assessments have been made, goods could be delivered in a personal/domestic vehicle or a taxi, especially in emergencies”. True or False?

• True

✓ False

Q16: The details on the temperature ticket as supplied by the driver do not line up, and the vehicle is a day late. What term beginning with ‘A’ are mismatched details like this known as?

• anomalies | 1

Q17: Where temperature controlled conditions are concerned, what is a logistics vehicle considered to be an extension of?

• The Office

• The Driver's cab

✓ The Warehouse

• The Receiving Customer or Pharmacy

Q18: “There must be a continuous uninterrupted record of temperatures made available for the purposes of inspection and compliance”. True or False?

✓ true

• false

Q19: Regarding the Unloading Procedures, who should sign the documents confirming all required checks have been performed?

• The nearest available manager

• Anyone on the premises

✓ The person responsible for undertaking the checks

Q20: When must the storage conditions of the product as cited on the product label be observed?

• End of the day

• Beginning of the day

✓ At all times

• Whenever it feels warm or cold

Q21: The Expiry Date is a mandatory item that must be checked during the picking process. Select three other things that must be checked to ensure the correct item/s are picked.

✓ Batch No.

• Weight

✓ Product / Presentation

• Colour

✓ Quantity

• Size

Q22: All commercial storage units must be fitted with appropriately located alarm systems that are both ______ and ______. (Select the correct words)

✓ Visual

• Discreet

• Not too loud

✓ Audible

• Timed to switch on and off through the week

Q23: Picking Activity should be documented electronically or manually in accordance with …what?

• ALPRO

✓ ALCOA

• COALA

• LOACO

Q24: Rats, mice, crawling and flying insects are some of the animals that can get into storage areas. What are they otherwise collectively known as?

• pest | 1 pests | 1

Q25: Where should packing take place?

• Anywhere there's room

✓ In a Designated Area

• On the truck before it leaves

Q26: How often do you think bins must be checked (and emptied if necessary)?

• Once a week

✓ Daily

Q27: What is the primary aim of all procedures throughout GDP, including packing?

• Profit

• Annual Bonus

✓ Patient Safety

• Bigger Premises

Q28: You see a fellow employee drop their discarded lunch foodstuff into a bin inside the storage area. Is this a good practice?

• no | 1 no it is not | 1 no it isn't | 1 no it's not | 1

Q29: In the event of emergencies, when should your RP be available?

• Office Hours only

• 6 days a week flexible

✓ 24 hours a day, every day

• Every day except bank holidays

Q30: What 2 things should the loading bay NOT be when not in use?

• Clean

✓ Used as a temporary storage area

• Unobstructed

✓ Used as overflow parking area

• Closed

Q31: What must packed goods be protected from? Choose 4 options.

✓ Extremes of temperature

✓ Moisture

• Marker Pens / Stickers

✓ Pests

✓ Contamination

Q32: It is summer. The fly population is at its peak, and pest control vigilance must also be heightened. Select the correct/permitted methods of dealing with flying insects.

✓ Fly Paper (subject to Risk Assessment)

• Rolled Up Newspaper

✓ Ultra-violet/Electric fly traps

• Electric Fly Swatters

• Fly Spray / Flying Insect Killer

Q33: During unloading, where should the keys to the vehicle be kept?

• On a magnet

✓ Goods-In Office Safe

• Under the receptionist's desk

• On the driver's personal key fob

Q34: Where should unloaded products be placed once removed from the vehicle?

• In the yard next to the vehicle

✓ Checking/Inspection Area

• In a warehouse gangway

• Anywhere possible

Q35: Give three reasons why you would have temperature and humidity control.

✓ To avoid loss of efficacy of the products

• To keep the staff warm

✓ to prevent damage to the goods

✓ to be in compliance

Quiz: Warehouse Operational GDP & Thermal Compliance – POST TEST

Q1: “It’s not written down as a procedure but you’ve done it anyway. As long as you tell the RP, this is acceptable”. True or False?

✓ False

• True

Q2: Where temperature controlled conditions are concerned, what is a logistics vehicle considered to be an extension of?

• The Office

• The Driver's cab

✓ The Warehouse

• The Receiving Customer or Pharmacy

Q3: “There must be a continuous uninterrupted record of temperatures made available for the purposes of inspection and compliance”. True or False?

✓ true

• false

Q4: Regarding the Unloading Procedures, who should sign the documents confirming all required checks have been performed?

• The nearest available manager

• Anyone on the premises

✓ The person responsible for undertaking the checks

Q5: During unloading, where should the keys to the vehicle be kept?

• On a magnet

✓ Goods-In Office Safe

• Under the receptionist's desk

• On the driver's personal key fob

Q6: When must the storage conditions of the product as cited on the product label be observed?

• End of the day

• Beginning of the day

✓ At all times

• Whenever it feels warm or cold

Q7: You see a fellow employee handling products who appears to be very ill. What do you do?

• Give them medicine

• Make them a coffee

✓ Report to line manager / RP

• Suggest they do a different task elsewhere

Q8: Where should unloaded products be placed once removed from the vehicle?

• In the yard next to the vehicle

✓ Checking/Inspection Area

• In a warehouse gangway

• Anywhere possible

Q9: All commercial storage units must be fitted with appropriately located alarm systems that are both ______ and ______. (Select the correct words)

✓ Visual

• Discreet

• Not too loud

✓ Audible

• Timed to switch on and off through the week

Q10: What four items are not permitted in the storage areas?

✓ Food

• Watches

✓ Drinks

✓ Smoking/Vaping material

✓ Personal Medication

• iPads

Q11: One of the checks to be made is that the goods have been transported under “appropriate conditions”. What does this mean?

• The vehicle is dry.

✓ Required storage conditions as described by the manufacturers or on the outer packaging.

• Transported on a day with stable weather.

Q12: Rats, mice, crawling and flying insects are some of the animals that can get into storage areas. What are they otherwise collectively known as?

• pest | 1 pests | 1

Q13: Which type of products MUST be given priority when unloading commences? Choose 3 options.

✓ Chilled

• Herbal Medicines

✓ Controlled Drugs

• Ambient Liquids

✓ Cytotoxic

Q14: If you receive a product that appears to have been tampered with, or where the packaging appears to be sub-standard or different, what could it potentially be?

• Poorly packaged at the supplier outlet

✓ A Falsified Medicine

• Badly handled by the supplier

Q15: How often do you think bins must be checked (and emptied if necessary)?

• Once a week

✓ Daily

Q16: What does FEFO stand for?

• first expiry first out | 1 first expire first out | 1 first expiry, first out | 1 first expire, first out | 1

Q17: You see a fellow employee drop their discarded lunch foodstuff into a bin inside the storage area. Is this a good practice?

• no | 1 no it is not | 1 no it isn't | 1 no it's not | 1

Q18: Some products appear to have sustained damage to the packaging and a few have failed/broken tamper evident seals. Where should these be put (1) and who should make a decision on them (2)?

• The Manager

✓ Quarantine

• In a side room

• A competent picker/packer

✓ The RP

• In the Good-In / Loading Bay area

Q19: What 2 things should the loading bay NOT be when not in use?

• Clean

✓ Used as a temporary storage area

• Unobstructed

✓ Used as overflow parking area

• Closed

Q20: The Expiry Date is a mandatory item that must be checked during the picking process. Select three other things that must be checked to ensure the correct item/s are picked.

✓ Batch No.

• Weight

✓ Product / Presentation

• Colour

✓ Quantity

• Size

Q21: It is summer. The fly population is at its peak, and pest control vigilance must also be heightened. Select the correct/permitted methods of dealing with flying insects.

✓ Fly Paper (subject to Risk Assessment)

• Rolled Up Newspaper

✓ Ultra-violet/Electric fly traps

• Electric Fly Swatters

• Fly Spray / Flying Insect Killer

Q22: Picking Activity should be documented electronically or manually in accordance with …what?

• ALPRO

✓ ALCOA

• COALA

• LOACO

Q23: Potential improvements to warehouse structure and procedures can be proposed through the Change Control process. Who is able to suggest these changes?

• The RP Only

• Management Only

✓ Anyone

• Licence Holder Only

Q24: Where should packing take place?

• Anywhere there's room

✓ In a Designated Area

• On the truck before it leaves

Q25: What is the acronym (initials) of the standard contract model that applies to goods being shipped internationally by road?

• CMR | 1 CMR Delivery Note | 1 Delivery note CMR | 1

Q26: What is the primary aim of all procedures throughout GDP, including packing?

• Profit

• Annual Bonus

✓ Patient Safety

• Bigger Premises

Q27: What do the initials “MAWB” mean?

• Master Airway Bill | 1

Q28: In the event of emergencies, when should your RP be available?

• Office Hours only

• 6 days a week flexible

✓ 24 hours a day, every day

• Every day except bank holidays

Q29: There are two main documents presented as National transport Documentation. One is a delivery note. What is the other?

✓ ASN
- advanced shipping notification

• BOL
- bill of lading

• MAWB
- master airway bill

Q30: What must packed goods be protected from? Choose 4 options.

✓ Extremes of temperature

✓ Moisture

• Marker Pens / Stickers

✓ Pests

✓ Contamination

Q31: What do the initials “ASN” mean?

• Advance Shipping Notice | 1 Advanced Shipping Notice | 1 Advance Shipping Notification | 1 Advanced Shipping Notification | 1

Q32: What should be recorded when a delivery arrives? Choose 4 options.

✓ Your name

✓ Driver name / i.d

• Weight of the vehicle

✓ Date and time

✓ Registration of vehicle

• Weather conditions

Q33: "As long as precautions and risks assessments have been made, goods could be delivered in a personal/domestic vehicle or a taxi, especially in emergencies”. True or False?

• True

✓ False

Q34: What five words does the acronym “ALCOA” stand for? Name them in order.

• attributable legible contemporaneous original accurate | 1 attributable, legible, contemporaneous, original, accurate | 1

Q35: The details on the temperature ticket as supplied by the driver do not line up, and the vehicle is a day late. What term beginning with ‘A’ are mismatched details like this known as?

• anomalies | 1

What you need to know about…

Quiz: what you need to know

flat-file-questions

All Questions (Site-wide)

Boots GDP Training: 28/08

Protected: Corrective Action Preventive Action

Data Integrity

Driver Training

Falsified Medicines

GDP Awareness Training

GDP Awareness Webinar Assessments

GDP for RPs and Management

GDP Licensing Requirements

GDP Obligations of the Licence Holder

Good Distribution Practice – Change Control

Protected: Good Distribution Practice and Quality Management

Good Distribution Practice Awareness – 2023/24

Good Distribution Practice: Chapters 6-10 of the EU Guidance 2013/C 343/01

Introduction to Auditing

Introduction to Pharmacovigilance in Good Distribution Practice

Medical Devices Awareness Training

Non-Conformance And Deviation Management (GDP)

Online GDP Webinar – GDP for RPs and Management

Outsourced Activities and Responsibilities of the Licence Holder and Responsible Person

Pest Control Training

Responsible Person for import (RPi)

Steve – Test Course

The Global Supply Chain

Unlicensed Medicines

Warehouse Cleaning and Personnel

Warehouse Operational GDP & Thermal Compliance

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