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The revision of Annex 15

Qualification and validation by public consultation


© Sanofi Pasteur 2008 / David W. Coulter Photography
Comments on the project will be received until 31 May 2014.

Annex 15 : Qualification and validation of the European Guide to Good Manufacturing Practice (EU GMP) is being revised. On 6 February the European Commission launched the public consultation phase for the draft text. The actors concerned have until 31 May 2014 to comment on the document.

This first revision of Annex 15 aims to take account of the changes made to other sections of Part I of the Guide, to Annex 11, to ICH’s Q8, Q9, Q10 and Q11, and to the QWP guide on the validation of processes and changes in manufacturing techniques. The latest date for the entry into effect of the new version has not yet been determined.

Comments should be sent to and

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