On Aug 22, 2022, EU Commission released Annex 1- Manufacture of Sterile Medicinal Products. It is coming into operation on Aug 25, 2023 (except the part 8.123 will be operated on Aug 25, 2024).

The intent of the Annex is to provide guidance for the manufacture of sterile products, ensuring that microbial, particulate and endotoxin/pyrogen contamination is prevented in the final product. It provides general guidance that should be used in the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products applying the principles of Quality Risk Management (QRM).

You can click the original article to learn more: Annex 1- Manufacture of Sterile Medicinal Products

*This news is from EU Commission.