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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. …

Manufacture of Investigational Medicinal Products – Frequently Asked Questions

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice
accurately measuring ingredients into a petri dish

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 …