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Inside the Inspectorate

PIC/S 2016 - Manchester

PIC/S 2016 Logo

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

Birthday cake with one lit candle

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.

2015 EU GCP Inspectors Electronic Data Integrity Workshop

Posted by: , Posted on: - Categories: Events and symposia, Good clinical practice, Inside the Inspectorate
Inspectors Working Group at the EMA

In October 2015 a number of MHRA GCP Inspectors attended the GCP Inspectors Working Group Workshop hosted by the European Medicines Agency (EMA) in London. This is an annual training event originally held for EU Good Clinical Practice (GCP) Inspectors that …

The GPvP inspectorate promote compliance and best practice at 2 successful events

EU Inspector Training: GPvP Inspectors from the MHRA, EU and beyond and EMA staff who coordinated the event.

Late last year the GPvP inspectorate ran its own symposium and contributed heavily to the EU pharmacovigilance inspector training event. GPvP symposium The GPvP inspectorate held a sell-out symposium in London in November attended by approximately 350 delegates. GPvP inspectors highlighted requirements, …

PIC/S - Press release and news of MHRA chair in 2016/17

Attendees at the 2015 PIC/S Annual Seminar, Indonesia

Back in October I attended, with MHRA colleagues, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) committee meeting and annual seminar that was this year hosted by the Indonesian National Agency for Drug and Food Control (NADFC). In the new year I'll …

Helping us to help you – 5 top tips for making enquiries to the MHRA Inspectorate

Helping us to help you by a) check our blog/pages of the website, b) be specific by which GXP your query relates to c) be specific about what your query relates to d) be specific about which company/site your query relates to e) give your proposal of what you intend to do

The MHRA Inspectorate receives several hundred enquiries via email each year. Answering queries is one of the key ways we support industry. It provides reassurance to our stakeholders, aiding them in their decision-making processes, helping to ensure they don’t fall …

Defective Medicines Report Centre (DMRC): an overview of our work

Posted by: , Posted on: - Categories: Compliance matters, Inside the Inspectorate, Wider MHRA
Members of the DMRC team at MHRA

Joiners and leavers Those of you that have contacted the Defective Medicines Report Centre (DMRC) recently may have encountered some new names – I started as manager of the DMRC team in early April, joining Christine Cox and Alison Bunce. Also …

MHRA support for innovation - Inspectorate input to case studies

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice, Inside the Inspectorate
Clockwise from top left. Images courtesy of: The Cell Therapy Catapult; BTG Plc; AstraZeneca; Fujifilm Diosynth Biotechnologies; Eisai.

MHRA has now published 7 case studies highlighting the work of our Innovation Office and showing how we help organisations that are developing innovative medicines, medical devices or using novel manufacturing processes to effectively navigate regulatory processes, so they can progress their products …

The British Pharmacopoeia's new website - setting the standards

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice, Inside the Inspectorate, Wider MHRA

The launch of the new integrated British Pharmacopoeia website this week presents a great opportunity to explore this other group within the Inspection, Enforcement & Standards Division of MHRA. The British Pharmacopoeia (BP) makes an important contribution to the role of MHRA …