Glossary
Contamination Control Strategy (CCS)
A plan that brings facilities, equipment, processes, people, and monitoring together to control microorganisms, endotoxin and pyrogens, and particles.
Details
A CCS is a documented system that links the contamination critical control points of the whole facility with the design, procedural, technical, organisational, and monitoring controls, as one strategy whose preventive effect can be assessed. Inspections cite a CCS that is no more than a list of individual SOPs, or that omits the interaction of facility, personnel, utilities, suppliers, interventions, and trends, and management review. Check the CCS itself, the underlying risk assessments, facility and process drawings, validation and monitoring trends, and change control, product quality review, and management review.
