The revised Annex 1 (25. August 2023) requires significant adjustments from European manufacturers of sterile products, including training aseptic techniques, understanding fundamental principles, and ongoing assessments for qualification.
Cleanroom personnel must now be trained according to certain principles and the assessment of their performance need to be objective. Sterile manufacturers are faced with the challenge to integrate these new standards and formulate a detailed, facility-specific “Contamination Control Strategy” (CCS). This means that manufacturers need to identify and assess the risk of contamination in their processes and procedures, explore mitigation options, and define preventive actions.