As with most activities in clinical trials, the development of electronic systems is playing an increasing role in methods for data collection. As inspectors we are therefore continually seeing new systems while out and about on inspection, and adapting our …
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). …
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.
Every batch of medicinal product must be certified by a Qualified Person (QP) of the EU manufacturer or importer before being released for sale. The certifying QP takes responsibility for ensuring that each batch has been manufactured and checked in …
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. …
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 …
Last week, our colleagues from the agency’s Enforcement team, along with the National Crime Agency, conducted one of their biggest-ever operations to take down unlicensed erectile dysfunction medicines.
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 …
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 …
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 …
