Good laboratory practice

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

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.

PIC/S meeting - February 2017

Posted by: Mark Birse, Posted on: 13 March 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

From 8 to 10 February 2017, the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland

Too much pressure: a behavioural approach to Data Integrity (Part 1)

Posted by: David Churchward, Posted on: 10 March 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

Global regulatory collaboration relating to data integrity remains a priority for MHRA and its international partners.

Who inspects the Inspectors? (Part II)

Posted by: Ian Jackson, Posted on: 10 January 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate, Wider MHRA

In the October blog post we told you about the successful audit of the GMP Inspectorate under the JAP programme. Later that month the entire Inspectorate was assessed as part of the BEMA programme.

Helping us to help you

Posted by: Michelle Yeomans, Posted on: 5 January 2017 - Categories: Compliance matters, Good distribution practice, Good laboratory practice, Good manufacturing practice, Wider MHRA

6 top tips for applicants submitting a Manufacturing Authorisation application or variation

2016 MHRA Laboratories Symposium - Your Questions

Posted by: Lynsay Hunter, Posted on: 14 December 2016 - Categories: Events and symposia, Good clinical practice, Good laboratory practice

My name is Lynsay Hunter and I am the newest recruit to the MHRA laboratories inspection team, having previously worked in a variety of laboratory and quality assurance roles. My first MHRA event was the annual laboratories symposium held in …