EMA – Public consultation: Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products – Annex 15 – Qualification and validation
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.
The Concept Paper on the revision of Annex 15 of the guidelines on Good Manufacturing Practices is open to consultation until 9 April 2026.
Templates and other open consultations can be found on the EMA Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (28 mars 2026). EMA – Public consultation: Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products – Annex 15 – Qualification and validation. ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/15ysp
