by Paradigm Shift Consulting | Feb 18, 2021 | Responsible Person, Auditing, Change Control, Data, Deviations, Falsified Medicines Training, GDP, Licensing, Management, MHRA, Outsourcing, RPi, Training
The EU Guidance 2013/C 343/01 clearly outlines the 12 duties of an RP (Responsible Person) in Chapter 2.2. Each of these duties will require the RP to have a high standard of knowledge on Good Distribution Practice; meaning that it is crucial that they have extensive...
by Paradigm Shift Consulting | Feb 4, 2021 | Documentation, Data, GDP, Management, MHRA, Responsible Person, RPi, Training
Good Documentation Practice Documentation such as Standard Operating Procedures (SOPs) and records, are a crucial part of an effective Quality Management System (QMS). They make up all procedures, processes and evidence required for you to ensure that you’re in...
by Paradigm Shift Consulting | Jun 24, 2020 | Change Control, Deviations, Documentation, GDP, Management, Non-Conformance, Responsible Person, RPi, Training
Change Control Processes A Change Control process will always need to be performed when changes are made to a system, piece of equipment or product. The process must ensure that all changes are identified, planned and implemented in a way that’s regulated and...
by Paradigm Shift Consulting | Jan 31, 2020 | Inspection, Auditing, GDP, Management, MHRA, Responsible Person, RPi, Training
Self-Inspection and Third-Party Audits are an important part of maintaining compliance throughout the company. During a self-inspection you should find any deviations or failures within your operations, and from there you can start to make improvements to your...
by Paradigm Shift Consulting | Jan 7, 2020 | Inspection, Auditing, Documentation, GDP, GMP, Licensing, Management, MHRA, Responsible Person, RPi
MHRA inspection – Be Ready! So what does this mean? MHRA inspection Preparation is important especially if you are worried about non-compliance. Carry out a self-inspection and compare your operations against the guidance, to ensure that you are compliant (at...
by Paradigm Shift Consulting | Nov 13, 2019 | Training, GDP, Management, MHRA, Responsible Person, RPi, Warehouse
Why is Competency Based Training Important? It is essential that every member of staff is confident in their role and understands how to follow procedures to effectively complete tasks in accordance with what is set out in the GDP guidelines, and competency must be...
