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Good laboratory practice

Joining and working for the Inspectorate

Reaching for the sky

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 …

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

PIC/S Seminar Delegates

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.

MHRA data integrity guidance: 18 months on

MHRA has produced draft GxP data integrity guidance for industry and we welcome your comments”

Eighteen months have passed since the MHRA published its GMP data integrity guidance. Since then we have seen pharmaceutical industry make significant effort to implement the guidance globally. It has been encouraging to see industry stakeholders and regulatory partners adopting …

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.

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 …

Risk-based GLP quality assurance programme

Posted by: , Posted on: - Categories: Compliance matters, Good laboratory practice
Scrabble pieces spelling out the word risk placed in a measure to detail measuring and managing risk

I am pleased to share the news that the UK Good Laboratory Practice Monitoring Authority's (UK GLPMA) guidance on the implementation and maintenance of a risk-based GLP quality assurance (QA) programme has been published. The GLPMA have for some time recognised there …