Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation

18th February 2026

Summary: This concept paper aims to outline the rationale, objectives, and proposed changes for the targeted update of Annex 15, Qualification and validation, of the Good Manufacturing Practice (GMP) guide, that is common to the Member States of the European Union (EU)/European Economic Area (EEA) as well as to the Participating Authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The aim of the revision is to extend the scope of the annex to active substances manufacturers and to consider the revision of ICH guideline Q9 (R1) on quality risk management.

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