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Terry Madigan

I joined the MHRA as a GDP Inspector in 2009. My position involves inspecting UK organizations that wholesale medicines. I previously worked in the pharmaceutical industry for 20+ years and was involved in research, development and within QA functions in manufacturing companies.

A Practical example of applying Quality Risk Management in GDP – Transportation Risks

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice
Scrabble pieces making up the word 'risk'.

Quality Risk Management (QRM) is a requirement of Good Distribution Practice (GDP). It underpins good design and maintenance of a GDP quality system and provides an approach that enables the quality system to be safe for patients, efficient and effective through identification of risks, and facilitates proportionality of mitigation.

How to manage temporary GDP process changes and risks through the COVID-19 pandemic

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice
Lady with a face mask and virus particles representing Covid infront of her

During the Covid-19 pandemic you may need to adjust how you operate. Such changes should be documented either as deviations, change controls or similar and incorporate quality risk management principles.