by Paradigm Shift Consulting | Dec 21, 2021 | Inspection, Change Control, Deviations, GDP, Management, MHRA, Non-Conformance, Responsible Person, Training, Warehouse
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...
by Paradigm Shift Consulting | Dec 21, 2021 | Responsible Person, Auditing, GDP, Inspection, Licensing, Management, MHRA, Paradigm, RPi, Training
The Contract RP’s Identity A Contract Responsible Person (Contract RP) plays the same role as a ‘regular’ RP but they are not a direct employee of the company they are an RP for. They should not have any commercial interest in the company that...
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...
