Annex 15

White Paper – EU GMP Guide – Annex 15 Qualification & Validation draft released


This White Paper reviews the proposed changes to Annex 15 of the EU GMP guide in detail. The draft of the revised Annex 15 was released in February 2014 by the European Commission. The draft version is based on an EMA Concept Paper that was published in November 2012. A review of the Concept Paper carried out back in 2012 can be found on the PharmOut website here.


This White Paper is applicable to audiences as identified below:

  • Those responsible for Commissioning, Qualification and Validation activities for facilities, systems, utilities and equipment for the manufacture of medicinal products.



The list below provides prerequisites for the users of the Technical Paper:

  1. Familiarity with Annex 15 Qualification & Validation of the EU GMP Guide or the PIC/S GMP guide
  2. General Knowledge of Qualification and Validation of facilities, utilities, systems and equipment

You can download the White Paper here or read an updated blog.

View all White Papers available from PharmOut

Note – Annex 15 Qualification and Validation is now finalised and published you can find the final guidance here.