After many years, the final revision to Annex 1 “Manufacture of Sterile Medicinal Products,” under the The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, was published today, and will go into effect August 25, 2023.


The intent of the Annex is to provide guidance for the manufacture of sterile products. However, some of the principles and guidance, such as contamination control strategy, design of premises, cleanroom classification, qualification, validation, monitoring and personnel gowning, may be used to support the manufacture of other products that are not intended to be sterile such as certain liquids, creams, ointments and low bioburden biological intermediates, but where the control and reduction of microbial, particulate and endotoxin/pyrogen contamination is considered important. Where a manufacturer elects to apply guidance herein to non-sterile products, the manufacturer should clearly document which principles have been applied and acknowledge that compliance with those principles should be demonstrated.


Deadline for coming into operation:
– 25 August 2023 : one year from the date of publication in Eudralex Volume 4
– 25 August 2024 : two years from the date of publication in Eudralex Volume 4 for point 8.123