The MHRA publishes data on common deficiencies discovered during routine inspections of WDA licensed premises.

The most common deficiencies were found with examples in regards to each chapter of the EU Guidelines 2013/C 343/01 and the Human Medicine Regulations (2012). Although deficiencies vary in frequency year on year, the top 5 recurring deficiency areas based on MHRA publications and GDP non-compliance reports were:

1. 1. 1. Deficiencies in the Quality Management System (QMS): This is a broad category but consistently ranks highly. It includes issues such as:

         • Lack of a fully implemented and maintained QMS.

         • Insufficient scope of management reviews, failing to include deviation analysis or effective oversight.

         • Poor or no evidence of effective implementation of change control, risk management, deviation capture, and CAPA (Corrective and Preventive Action) reporting.

         • Inadequate or missing written procedures, or procedures that are not followed in practice.

      2. Inadequate Responsible Person (RP) Oversight and Fulfillment of Duties: The RP is central to GDP compliance. Common deficiencies related to the RP include:

         • The RP not fulfilling all their responsibilities as defined in the regulations and GDP guidelines.

         • Lack of sufficient resources or personnel allocated to the RP role.

         • RP failing to ensure the accuracy and quality of records, or to ensure that suppliers’ licenses are approved.

         • Insufficient knowledge of GDP and the regulations, or lack of proper induction and ongoing training.

      3. Premises and Equipment Deficiencies, particularly Temperature Control: This category covers the physical aspects of storage and distribution:

         • Inadequate or unqualified storage facilities (e.g., lack of proper quarantine areas for cold chain or ambient products).

         • Poor maintenance and cleaning records for storage areas.

         • Issues with temperature monitoring equipment, such as uncalibrated thermometers, incorrect installation, or considerable gaps in contemporaneous temperature records.

         • Computerized systems not adequately described within the quality system, or lacking proper validation, backup, and restoration processes.

      4. Supplier and Customer Qualification Issues: Ensuring the legitimacy and compliance of supply chain partners is crucial:

         • Insufficient or inadequate systems for the qualification and ongoing verification of suppliers (e.g., failure to check for valid licenses, or to perform due diligence).

         • Lack of proper qualification of customers, leading to medicinal products being supplied to unauthorized persons.

         • Failure to monitor unusual or irregular sales patterns, particularly for controlled drugs or high-risk products, which could indicate diversion.

      5. Inadequate Documentation and Record Keeping: Comprehensive and accurate documentation is a cornerstone of GDP:

         • Lack of formal processes for document control and retention.

         • Missing or incomplete historic trading records.

         • Documents (e.g., delivery notes) not accurately reflecting the licence holder making the supply, leading to a lack of traceability.

         • Purchase and sales documentation not being adequately maintained or available.

Common Deficiencies – Quality Systems

This area (Chapter 1.2 in the EU GDP guidelines) was where the largest number of deficiencies were found during MHRA inspections since 2016 and since. Considering that the Quality System is the backbone of the company, this is quite a worrying fact as it is crucial that it is compliant and effective. Examples of the common deficiencies found during inspections regarding the quality system were:

• • Out of date contracts with third parties and no formal review process for outsourced activities.
  • Management reviews did not include analysis on deviations.
  • Risk Management processes were not adequately implemented or recorded.
  • Deviations being closed before a CAPA has been implemented.

Frequently reviewing your quality system with management reviews and self-inspections will allow you to find any problems and deficiencies or anything that is missing or needs updating as quickly as possible, meaning you can take the correct actions to ‘fix’ them before any serious consequences or risks arise.

Common Deficiencies – Transportation

This area includes how the medicinal products are moved between companies and any related documents, records or processes. Some examples of common deficiencies here are:

• • Risk assessments for temperature control were lacking in detail and contained assumptions about the UK weather conditions.
  • Use of uncalibrated equipment for temperature monitoring.
  • No evidence that products had been shipped within the acceptable temperature conditions.

If there are deficiencies with your transportation operations including risk assessments and temperature controls, it could lead to deviations regarding the conditions of the medicinal products, which could mean that the integrity of the products are impacted causing a potentially serious risk to the safety of the end user (patients).

If you are using a third-party service provider for transport you must ensure that you have made it clear what their responsibilities are as well as the conditions the products must be kept under during transport. You will need to have evidence of compliance and that there were no deviations during the transportation of products, which must be checked before you accept products from a vehicle.

The Responsible Person

Your RP is responsible for the compliance of the entire company, meaning they will need to have a high level of understanding of Good Distribution Practice and how to implement and maintain the guidelines. Any problems with your RP could lead to issues throughout the rest of your operations and cause risks to the products and patients. Some of the common deficiencies we had discovered were:

• • The RP could not show that they had sufficient knowledge of Good Distribution Practice.
  • The RP had no training record in place – no evidence of his ongoing awareness and competence.
  • The RP did not fulfil the responsibilities required to meet the conditions of the licence.

Training and Support

Training on Good Distribution Practice will be needed continuously to ensure that the RP’s knowledge is up to date and sufficient so they can effectively carry out their duties. If the RP does not know what is required of them this could lead to a number of deficiencies throughout the company and if an inspector finds that your RP is not effective in their role your licence could be suspended or they could be removed by a forced variation.

These are just some examples of common deficiencies that you should be looking for during self-inspections and they show that there are a lot of things that need to be worked on by companies when it comes to compliance with Good Distribution Practice guidelines. Your company should ALWAYS be GDP compliant!

Paradigm Shift Consulting offers guidance on compliance and we can conduct a third-party audit of your site. Contact us using the form below for more information on the services we offer, including our forthcoming UK GDP Association C.I.C.

If you need GDP training, visit our GDP Training Courses and view the range of courses on offer. See also our Non-Conformances and Deviations Management course.