EMA: Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products

This concept paper addresses the need to update annex 1 (manufacture of sterile medicinal products) of the good manufacturing practice (GMP) guide. Annex 1 is common to the Member States of the European Union/European Economic Area as well as to the participating authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).