Inside the Inspectorate

Organisations:	Medicines and Healthcare products Regulatory Agency

MHRA Inspectorate Organogram

Mark Birse, 11 May 2017 — Inside the Inspectorate

We have today updated the sidebar of the MHRA Inspectorate Blog to provide access to the MHRA Inspectorate organogram.

Losing GSi – MHRA emails are changing

Mark Birse, 10 April 2017 — Inside the Inspectorate, Wider MHRA

From 10 April, we are removing .gsi from our email addresses. Technology has changed a lot since the introduction of the Government Secure Intranet (GSi) in 1996

Overview of compliance management escalation processes used by the GMP Inspectorate

Alan Moon, 6 February 2017 — Compliance matters, Events and symposia, Good distribution practice, Good manufacturing practice, Inside the Inspectorate

At the GMDP Symposium 2016, Andrew Hopkins and I gave a presentation about the Inspection Action Group (IAG) and Compliance Management Team (CMT), to highlight the systems and processes in place for when compliance issues are identified at manufacturing and …

Who inspects the Inspectors? (Part II)

Ian Jackson, 10 January 2017 — 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

Mark Birse, 2 December 2016 — 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

Diane Leakey, 17 November 2016 — 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?

Ian Jackson, 5 October 2016 — 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

Philip Rose, 9 September 2016 — 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

Sandra Bax, 10 August 2016 — 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

Mark Birse, 1 August 2016 — 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.