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Good distribution 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.

Qualification of customers, what wholesalers need to know

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice
Blister pack of mediicnes

In my last post I talked about the importance of ensuring medicines are only obtained from qualified suppliers. Equally important is the obligation distributors have in ensuring that only wholesalers or persons entitled to supply or administer medicines receive medicinal products. …

Refrigerated medicinal products, part 2: Transportation, packing, temperature management, the use of third party couriers and returns – some things to consider

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice
Refrigerated transportation

This is the second of two blog posts dealing with the management of refrigerated medicinal products and like the first, draws on some of the findings from GDP inspections, references to the EU GDP Guidelines 2013, the Green Guide and …