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Compliance matters

Joining and working for the Inspectorate

Reaching for the sky

When I applied to join the Inspectorate I was working as a Qualified Person. I’d been on the receiving end of many inspections and thought that the role looked to be a hugely interesting one with a great amount of …

GPvP inspections of contract service providers - August 2016 update

Posted by: , Posted on: - Categories: Compliance matters, Good pharmacovigilance practice
Jigsaw piece with the word outsourcing

In July 2003 the Medicines and Healthcare products Regulatory Agency (MHRA) introduced a statutory pharmacovigilance inspection programme of marketing authorisation holders (MAHs) in the United Kingdom. The revisions to the pharmacovigilance legislation implemented in 2012 are supportive of the inspection of …

PIC/S - Press release and news of MHRA hosted meetings and seminar, July 2016

PIC/S Seminar Delegates

Just 4 weeks ago the MHRA hosted the PIC/S Committee meeting, PIC/S Executive Bureau meeting, and PIC/S Annual Seminar at the Museum of Science and Industry (MOSI) in Manchester.

MHRA data integrity guidance: 18 months on

MHRA has produced draft GxP data integrity guidance for industry and we welcome your comments”

Eighteen months have passed since the MHRA published its GMP data integrity guidance. Since then we have seen pharmaceutical industry make significant effort to implement the guidance globally. It has been encouraging to see industry stakeholders and regulatory partners adopting …

Temperature mapping – an introduction.

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice
Three thermometers with different temperatures

GDP Guidelines Chapter 3.2.1 “An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions. Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices …