by Paradigm Shift Consulting | Jul 14, 2025 | Auditing, Change Control, Documentation, GDP, Inspection, MHRA, Responsible Person, RPi
Producing an Audit Report: What Happens Next Once you have planned and performed a first party (internal) or second party (external) audit, it is imperative that you document your findings in a formal audit report. Regulatory inspectors expect a ‘show and tell’...
by Paradigm Shift Consulting | Mar 22, 2023 | Training, Auditing, Change Control, Data, Deviations, GDP, Inspection, Licensing, Management, MHRA, Non-Conformance, Outsourcing, Paradigm, Responsible Person, Temperature Management, Unlicensed Medicines, Warehouse
GDP for RPs and Management Webinar Online Webinar Struggling to keep up, or lost in the maze of GDP regulations? Do you want to check your business is compliant in Good Distribution Practice? Licence Holder or Senior Management and unsure of what your RP is expected...
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 | 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 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 | 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...
