What is Annex 1?

Effective August 2023, GMP Annex 1 establishes the regulatory standard for all sterile medical products sold in the EU and focuses on best practices for aseptic and terminal sterilization. The final section regarding lyophilization protocol became legally binding as of August 2024. While specific to the EU, these guidelines function as industry benchmarks that inform FDA and Health Canada inspection practices. 

Contamination Control Strategy (CCS) 

Central to Annex 1, the updated Contamination Control Strategy (CCS) combines different elements into a single document overviewing how manufacturers will record and evaluate data from the production process. The CCS should anticipate risks and provide details about how manufacturers will avoid cross-contamination, assure sterility, and control for biological containments and foreign particles. As part of contamination prevention, Annex 1 strongly encourages the use of isolators and RABS (Restricted Access Barrier Systems).  

Quality Management Systems  

Annex 1 also requires manufacturers to identify and prevent potential issues including facility design, standard procedures, supplier quality, and other aspects of quality risk management (QRM) through ongoing monitoring and revaluation. As part of the regulatory update, companies must implement a Pharmaceutical Quality System (PQS) into their workflow if one is not already in place. To help meet these standards, manufacturers are replacing dated equipment and providing team members with ongoing training.   

Conclusion 

Continuous improvement relies on the willingness and ability to close any technological or process gaps and to take a proactive approach to quality and risk management. Annex 1 will help keep the industry moving toward best practices in sterility to protect patient safety and ensure regulatory confidence for fill-finish products sold both inside and outside EU markets.