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.
Good manufacturing practice
The 2017 GMP Symposium was the riskiest ever! This year the theme of Risk Management ran throughout the various sessions at the event.
Potential patient safety issues, serious breaches of GMP or suspected criminal activity frequently trigger short notice or unannounced inspections
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.
The Inspectorate laboratories group conducts a diverse number of inspections both internationally and across the United Kingdom.
Today marks the start of the operational phase of the EU-FDA mutual recognition agreement
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.
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)
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.
A bite sized summary of our recent posting to the MHRA Inspectorate blog