PIC/S 2016 - Manchester

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

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

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. …

Manufacture of Investigational Medicinal Products – Frequently Asked Questions

Copyright-Savas Keskiner

The GMP Inspectorate works closely with the Clinical Trials Unit (CTU) at MHRA and regularly provides support to help answer a wide range of stakeholder queries which relate to the manufacture, import, labelling, licensing requirements and general handling of Investigational …

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

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 …

Notification to MS licence holders due to compliance concerns

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 …