The EMA has released for public consultation a concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products. The deadline for comments is 31 March 2015.

This 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).

The document is available by clicking here. Comments should be provided using this Template. The completed comments form should be sent to