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EU and EMA

Brexit impact on the MHRA?

Brexit causes questions to arise as to the future of the EMA, located in Canary Wharf, London and also about MHRA’s continued contribution to the regulatory control of drugs in the European Union (EU) …

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EU releases Annex 15 validation and qualification

On the 30th of March, the EU released its updated version of Annex 15 Qualification and Validation which will be effective on 01 October 2015. In this article, I will discuss the changes between the draft version and the revised Annex 15 version.

cross contamination risk

Dedicated facilities or not?

Only a brave person would try to guess where the EU GMP regulations are going for medicinal products produced in shared manufacturing facilities. At the moment, it is a little like gazing into a crystal ball, trying to understand the consensus of the many participating authorities involved, with their often strongly differing views based on their in-country experiences (disasters). Existing facilities really only have “Organisational Measures” to control the potential risks of cross-contamination, as often it is impractical to retrofit the “Technical Measures” as referred to in Chapter 3 and 5 in the EU GMP guidance.