Public consultation: revision of European Commission Guidelines on Good Manufacturing Practice for Medicinal Products

27 February 2014

On 6 February 2014 the European Commission launched the public consultation on the revision of Annex 15: Qualification and Validation. This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products, including validation of packaging. It is a GMP requirement that manufacturer’s control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process.
Stakeholders are invited to comment on the draft by 31 May 2014 at the latest (European Commission website, 6 February 2014).
Click here for more information on the public consultation.
Click here to download the draft of Annex 15 (140 kB).

This item is also included in our monthly overview, the NVC Members-only Update. If you have any questions, please contact us:, +31-(0)182-512411.