GMP: 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.