Annex 15: Qualification and Validation – Revision 2015

The new EudraLex  Annex 15 describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products.

Deadline for coming into operation: 1 October 2015

Download Annex 15

Now you can also review all public comments on Annex 15: GMP Major Developments Link