Contamination control strategy (CCS)

A documented, site-wide strategy that pulls together every control against microbial, particulate and pyrogen contamination (facility design, utilities, materials, personnel, cleaning, environmental monitoring) and shows how well they work as a whole. The requirement comes from the 2022 revision of EU GMP Annex 1, which PIC/S also adopted; Japan's MHLW, PMDA and prefectures have been PIC/S members since July 1, 2014. Japanese documents use the abbreviation CCS as often as the Japanese term. A CCS earns its keep by exposing gaps and weak points between existing controls, not by adding one more control.