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Compliance matters

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

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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 …

Transitional QPs for Investigational Medicinal Products (IMPs) - Update

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice
QP update

We are aware there is some concern for UK business and personal careers, over the status of transitional QPs that were recognised under the transitional arrangements provided in SI 2004/1031, when the Clinical Trials Directive was implemented in 2004. The …

Notification to MS licence holders due to compliance concerns

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice
Dropper dropping liquid into a bottle

In January 2015, MHRA published guidance to ‘specials’ manufactures, to provide an interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers. The GMDP Inspectorate have been concerned that some Specials manufacturers have not always been receiving written orders …

Good Distribution Practice - Qualification of suppliers, a helpful reminder of the 3 steps needed to assure supply chain integrity

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Front cover of the 2015 Green Guide

We have recently had a number of situations where companies have not understood the obligations placed on them by the Human Medicines Regulations 2012 Regulation 44 (2) and (3) and Good Distribution Practice in relation to qualification of suppliers. In …