GOV.UK
MHRA’s GXP data integrity guide published
The MHRA’s GXP data integrity guide has been published today.
Good manufacturing practice
Out of Specification Guidance
The issue faced when dealing with out of specification (OOS) results is as much a challenge now as it ever was. This post provides some guidance on how to handle OOS results.
GMDP Symposium 2017- GMP Days
The 2017 GMP Symposium was the riskiest ever! This year the theme of Risk Management ran throughout the various sessions at the event.
An Inspector Calls: Part 2, GMP Short Notice and Unannounced Inspections cont
Potential patient safety issues, serious breaches of GMP or suspected criminal activity frequently trigger short notice or unannounced inspections
Looking for a New Challenge in 2018?
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.
2018 MHRA Laboratories Symposium
The Inspectorate laboratories group conducts a diverse number of inspections both internationally and across the United Kingdom.
EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase
Today marks the start of the operational phase of the EU-FDA mutual recognition agreement
International regulators inspecting in the UK
The MHRA has seen an increasing number of inspections being conducted in both the UK and the rest of the EU by regulators from other countries.
PIC/S - Press release and news of TFDA hosted meetings and seminar, September 2017
From 11 to 15 September 2017 I attended the PIC/S Committee meeting, Executive Bureau meeting, and Annual Seminar hosted by the Taiwan Food and Drug Administration (TFDA)
Potential supply issues
The last couple of months have seen some catastrophic weather conditions across the globe. These can have a significant impact upon the pharmaceutical supply chain.