Inside the Inspectorate

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.

The 2017 Orange and Green Guides

Posted by: Mark Birse, Posted on: 2 December 2016 - Categories: Compliance matters, Good distribution practice, Good manufacturing practice, Inside the Inspectorate

The 2017 Orange and Green Guides are almost ready for publication.

Introduction of Office Based Risk Assessments for pharmacy collection sites

Posted by: Diane Leakey, Posted on: 17 November 2016 - Categories: Compliance matters, Good distribution practice, Inside the Inspectorate

Traditionally, GDP (Good Distribution Practice) inspectors visit sites to confirm that holders of Wholesale Dealer’s Authorisations (WDA) are compliant with the requirements of legislation.

Who inspects the Inspectors?

Posted by: Ian Jackson, Posted on: 5 October 2016 - Categories: Compliance matters, Good manufacturing practice, Inside the Inspectorate

In October 2015 the MHRA was audited under the Joint Audit Programme (JAP) for EEA GMP Inspectorates.

Joining and working for the Inspectorate

Posted by: Philip Rose, Posted on: 9 September 2016 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate

When I applied to join the Inspectorate I was working as a Qualified Person. I’d been on the receiving end of many inspections and thought that the role looked to be a hugely interesting one with a great amount of …

DMRC Reporting – Do’s and Don’ts

Posted by: Sandra Bax, Posted on: 10 August 2016 - Categories: Compliance matters, Good distribution practice, Good manufacturing practice, Inside the Inspectorate, Wider MHRA

Following on from the previous DMRC overview post, here are some Do’s (What, When & How) for reporting defects to the DMRC, and also some Don'ts to avoid.

PIC/S - Press release and news of MHRA hosted meetings and seminar, July 2016

Posted by: Mark Birse, Posted on: 1 August 2016 - Categories: Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate

Just 4 weeks ago the MHRA hosted the PIC/S Committee meeting, PIC/S Executive Bureau meeting, and PIC/S Annual Seminar at the Museum of Science and Industry (MOSI) in Manchester.

PIC/S 2016 - Manchester

Posted by: Mark Birse, Posted on: 28 June 2016 - Categories: Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate

The Medicines and Healthcare products Regulatory Agency (MHRA) UK is honoured to be the host of the 2016 PIC/S Seminar. This is an annual international event attended by both member and non-member authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). …

1st birthday - reflections on the last year of blogging

Posted by: Mark Birse, Posted on: 23 June 2016 - Categories: Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate, Wider MHRA

A year ago today we launched the MHRA Inspectorate blog. Now, after 12 months of activity it’s a good time to reflect on where we are and what’s to come.