EU GMP Annex 1: EMA plans the Revision of the Sterile Guide

At the beginning of February 2015, the European Medicines Agency (EMA) published a Concept Paper on the revision of Annex 1. Annex 1 of the EU GMP Guide is the Guideline for Europe which describes the requirements on the manufacture of sterile dosage forms. The reasons given for the revision are technological developments as well as the adaptation to the ICH Q9 and Q10 guidelines. The last, relatively extensive revision of Annex 1 dates back to 2007. The new version of Annex 1 should also include new technologies in sterile production - not previously covered - beside the adaptation mentioned.

The paper contains a very interesting paragraph which describes the necessity of a change if there is a revision of a pharmacopoeia monograph. Here, the method for the production of WFI (water for injection) without distillation is mentioned. This is all the more interesting as there is currently no information from the EDQM - the editor of the European Pharmacopoeia - that a change to this method is planned soon. So far, distillation only is allowed for the production of WFI according to the European Pharmacopoeia.

You can find the Concept Paper on the EMA webpage. The consultation deadline ends on 31 March 2015.

The revision of Annex 1 will also be a topic of the Pharma Congress on 24-25 March 2015 in Düsseldorf, Germany. There, Dr Jean-Denis Mallet - former head of the French GMP inspection authority - will give a Key-Note presentation on 24 March about the changes required to the most significant paper on sterile production.