EU Annex 1 In Practice: How A CDMO Builds A Modern Sterile Fill/Finish Facility

This piece walks through how CDMOs design sterile fill/finish facilities to meet EU Annex 1 standards, which also line up well with FDA and PMDA rules. Sterility can't be tested in—it has to be built into every step of aseptic processing. View the Pharmaceutical Quality System and Contamination Control Strategy, using risk management throughout the product lifecycle. Cleanrooms (Grades A–D) need proper pressure flows, smooth surfaces, filtered air, and validated transfers. Utilities like WFI, steam, and gases get full qualification to avoid contamination. Staff training cuts down on human-related risks, backed by sterile gowns and airflow tests. Monitoring tracks particles, microbes, and media fills to prove processes work. For audits, sponsors check validated setups, documented strategies, utility trends, and quality oversight. Annex 1 pushes risk-based control that works worldwide.