Monday, 16 November 2015

European Sterile Products Guidance Under Review


Annex 1 to the EU GMP Guide is under review. The annex focuses on sterile products. To consider what might be expected, Tim Sandle has written an article for American Pharmaceutical Review assessing what the new version might contain and some personal reflections about what it should contain.

“Annex 1 to the European Union Good Manufacturing Practice (GMP) guidelines is now under formal revision, with a concept paper issued during February 2015 and with a view to implement the new document during 2016. Annex 1 is a key part of European GMP for it affects the production and filling of sterile products. The document is also of global importance as manufacturing centers importing into Europe need to comply with the guidance. In addition, previous versions of the Annex have proven to be influential on other international regulators.”

The reference is:

Sandle, T. (2015) European Sterile Products Guidance Under Review, American Pharmaceutical Review, September / October 2015: 1-4

For a copy, please contact Tim Sandle

Posted by Tim Sandle