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 | Jan 28, 2021 | GDP
What are Outsourced Activities? Outsourced activities are any activities that are carried out for you by a third-party. For all outsourced activities there should be an in-depth written contract in place that clearly lays out the duties and responsibilities of both...
by Paradigm Shift Consulting | Jan 21, 2021 | Management, GDP, MHRA, Responsible Person, Training, Warehouse
An effective Quality Management System is essential for ensuring that your operations are GDP compliant. What is a Quality Management System? Your Quality Management System (QMS) will lay out everything that you need to do and includes all procedures, processes,...
by Paradigm Shift Consulting | Jan 6, 2021 | GDP, Change Control, Data, Deviations, Documentation, Management, Responsible Person, Temperature Management, Training, Warehouse
What are Standard Operating Procedures? Standard Operating Procedures (SOPs) are the documents that will set out all of the procedures used by your company, meaning they should mirror these processes. They are the backbone of your company’s Quality Management...
by Paradigm Shift Consulting | Dec 18, 2020 | GDP, Training
What is a CAPA? A Corrective and Preventive Action (CAPA) is taken to correct existing (corrective) or potential (preventive) deviations occuring or reoccuring in all and any areas of Good Distribution Practice compliance and procedures. If done correctly this...
