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 | 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...