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 | Outsourcing, Auditing, GDP, Licensing, Logistics, Management, Responsible Person, Warehouse
Contracts for Outsourced Activities Contracts are a requirement when working with a third-party service provider (outsourced activities), to be signed by you (the contract giver) and the service provider (contract acceptor), which makes it clear what the...
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 | 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...
