Glossary
Contamination Control Strategy (CCS)
A plan that brings facilities, equipment, processes, people, and monitoring together to control microorganisms, endotoxin and pyrogens, and particles.
Source · EU GMP Annex 1 (2022), Glossary, Contamination Control Strategy
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.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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• Weaknesses identified in the CCS were the followings: - The opening/closing mechanism of the automatic door leading to the Grade B filling room (type DORMA ED 100/ED 250 and the risks and necessary controls related to its mechanism were not captured.
EMA · EU GMP NCR (EudraGMDP) · 2026-02-03 -
In your response, we acknowledge your intentions to strengthen investigation requirements, perform a retrospective review of investigations, and review the facility’s contamination control strategy.
FDA · FDA Warning Letter · 2026-09-01
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
EU GMP Annex 1 (2022), Glossary, Contamination Control StrategyGRM Regulatory Glossary
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