Concept paper on revising annex 16 of the guide to good manufacturing practice: Certification by a qualified person and batch release

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Download document Concept paper on revising annex 16 of the guide to good manufacturing practice: Certification by a qualified person and batch release
Reference number EMA/INS/GMP/844118/2011
Status draft: consultation closed
First published 08/11/2011
Last updated 08/11/2011

Summary

Annex 16 of the guide to good manufacturing practice for medicinal products gives guidance on the certification and batch release of medicinal products within the European Union and European Economic Area.