Proposed changes to EU GMP Annex 1 – sterile manufacture
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Proposed changes to EU GMP Annex 1 – sterile manufacture

GMP Annex 1 – sterile manufacture In January PIC/S and the GMP/GDP Inspectors Working Group (on behalf of the EMA) agreed on a concept paper regarding the long awaited update to Annex 1, the primary GMP guidance on sterile manufacturing for Europe and PIC/S member countries. The current version of Annex 1 dates from 2007,…

Dedicated facilities or not?
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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.

Clinical Trial results reporting mandatory in EU from July 21

Clinical Trial results reporting mandatory in EU from July 21

From July 21 2014, clinical trial Sponsors must post results from their trials in the European Clinical trials Database (EudraCT) managed by the European Medicines Agency (EMA) for any interventional trials registered in EudraCT and for clinical trials that have ended within a certain period of time. Voluntary reporting had been encouraged from October last…