Good laboratory practice

MHRA’s GXP data integrity guide published

The MHRA’s GXP data integrity guide has been published today.

Out of Specification Guidance

Posted by: Lesley Graham, Posted on: 2 March 2018 - Categories: Compliance matters, Good laboratory practice, Good manufacturing practice

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.

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)

Missed our last few posts?

Posted by: Mark Birse, Posted on: 1 September 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

A bite sized summary of our recent posting to the MHRA Inspectorate blog

GLP Inspections metrics reflections

Posted by: Martin Reed, Posted on: 4 July 2017 - Categories: Compliance matters, Good laboratory practice

To help GLP organisations pro-actively improve compliance we are sharing the 2015 inspection metrics and examples also seen over the last 12 months

Too much pressure: a behavioural approach to Data Integrity (Part 2)

Posted by: David Churchward, Posted on: 30 March 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

The first post in this series described the importance of organisational behaviour on the success of data integrity control measures. Behavioural issues are often unsuitable for technical guidance, but the Inspectorate blog provides an opportunity to address this complex issue.