Concept paper on the revision of EU GMP Annex 1– manufacture of sterile medicinal products
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 extensiverevision 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 - theeditor 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 at EMA page. The consultation deadline ends on 31 March 2015.
Document details
Download document | Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice - manufacture of sterile medicinal products www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/02/WC500181863.pdf |
Reference number | EMA/INS/GMP/735037/2014 |
Status | draft: consultation open |
First published | 05/02/2015 |
Last updated | 05/02/2015 |
Consultation start date | 05/02/2015 |
Consultation end date | 31/03/2015 |
Email address for submissions | adm-gmdp@ema.europa.eu |
Summary
This concept paper addresses the need to update annex 1 (manufacture of sterile medicinal products) of the good manufacturing practice (GMP) guide. Annex 1 is common to the Member States of the European Union/European Economic Area as well as to the participating authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
