Contamination Control Strategy (CCS)

A planned, site-wide set of controls for micro-organisms, endotoxins and particles, required by EU GMP Annex 1 (2022). It covers facility and equipment design, utilities, raw materials, personnel, cleaning and disinfection, process controls, monitoring and validation, and explains how they work together. The CCS is a living document, reviewed regularly and after significant changes or adverse trends. Inspectors often ask for it first when reviewing a sterile site.