GMP Annex 1 For Sterile Manufacturing In The EU

The revised EU GMP Annex 1, effective August 2023, emphasizes a comprehensive Contamination Control Strategy (CCS) and mandates continuous environmental monitoring throughout production processes. It requires efficient detection of particles down to one micron in Grade A environments and zero microbial growth, necessitating high biological efficiency in monitoring equipment. The guidelines also stress the importance of species-level identification of contaminants and recommend the use of active air sampling methods over settle plates, which may have lower efficiency.

The updated Annex 1 introduces significant changes to the manufacture of sterile medicinal products, focusing on risk management and contamination control. It requires manufacturers to develop a holistic, facility-wide CCS, integrating quality risk management (QRM) principles. The document has expanded to 59 pages, reflecting its comprehensive approach.

To comply with Annex 1, manufacturers should implement a robust CCS that includes continuous environmental monitoring, efficient particle detection, and species-level identification of contaminants. Active air sampling methods are recommended over settle plates due to higher efficiency. Additionally, integrating QRM principles into the CCS is essential to meet the updated guidelines.