The revised EU GMP Annex 1, "Manufacture of Sterile Medicinal Products", became applicable on 25 August 2023 (with the lyophiliser sterilisation clause deferred to August 2024). It replaced a 2008 text with a much longer document built around a contamination control strategy (CCS).
Contamination control strategy
The CCS is a documented, living assessment of all controls that together minimise contamination risk: facility design, personnel, utilities, equipment, process, materials and monitoring. It is expected to be reviewed and updated, not written once.
Other areas of change
- Greater emphasis on quality risk management and on barrier technologies such as isolators and RABS.
- Clearer expectations for environmental and personnel monitoring, including trending.
- Pre-use post-sterilisation integrity testing of sterilising filters.
Impact on validation and quality staffing
Manufacturers exporting to the EU, and US sites inspected against EU expectations, needed validation engineers and QA specialists familiar with the CCS concept. Vakula supplied process and equipment validation consultants for several CCS gap remediation projects in 2023. See validation.