Revision of the EU GMP Guide – Annex 15

12 May 2015

On 30 March 2015, the European Commission published revised version of Annex 15: Qualification and Validation of the EU GMP Guide. The new annex will become effective on 1 October 2015. Comparing to current version of the annex, extensive changes have been made in some areas. Particularly, it relates to Process Validation and Cleaning Validation.