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

Posted by: grahamcarroll, Posted on: 5 February 2018 - Categories: Compliance matters, Events and symposia, 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.

An Inspector Calls: Part 2, GMP Short Notice and Unannounced Inspections cont

Posted by: Tracy Moore, Posted on: 9 January 2018 - Categories: Compliance matters, Good manufacturing practice, Inside the Inspectorate

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?

Posted by: Mark Birse, Posted on: 21 December 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate, Wider MHRA

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

Posted by: Lynsay Hunter, Posted on: 3 November 2017 - Categories: Compliance matters, Events and symposia, Good clinical practice, Good laboratory practice, Good manufacturing practice

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

Posted by: Ian Rees and Mark Birse, Posted on: 1 November 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice

Today marks the start of the operational phase of the EU-FDA mutual recognition agreement

International regulators inspecting in the UK

Posted by: Mark Birse, Posted on: 19 October 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

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

Posted by: Mark Birse, Posted on: 11 October 2017 - Categories: Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

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

Posted by: Ian Jackson, Posted on: 11 October 2017 - Categories: Compliance matters, Good manufacturing practice

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.