Annex 1 EU GMP 2023: What's New for Sterile Manufacturing

The new EU GMP Annex 1 , which came into force in 2023, has redefined the rules for sterile manufacturing. Among the main changes are the requirement to implement a documented Contamination Control Strategy (CCS) , strengthened environmental monitoring, and the preference for isolators and RABS over open systems.

During inspections, the most frequent observations concern generic CCS not calibrated to the process, outdated training and incomplete monitoring plans.

To meet these new challenges, companies must update SOPs and training programs, as well as validate monitoring plans based on historical data. Our Annex 1 Guide for Manufacturing Managers and QA contains operational checklists and flowcharts that help transform regulations into practical procedures, reducing the risk of non-compliance.

Want to delve deeper into contamination control strategy ? Our guides offer ready-to-implement templates.