EMA – Public consultation: Concept paper on revision of the guidelines on good manufacturing practice for medicinal products – Annex 6 manufacture of medicinal gases
This concept paper aims to outline the rationale, objectives, and proposed changes for the targeted update of Annex 6, Manufacture of Medicinal Gases, 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 carry out a limited review and update of the guideline to reflect industry’s current practices, including the use of new technologies and computerized systems.
The Concept Paper on the revision of Annex 6 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 revision of the guidelines on good manufacturing practice for medicinal products – Annex 6 manufacture of medicinal gases. ELSIBI. Consulté le 11 octobre 2026 à l’adresse https://doi.org/10.58079/15ysr
