How to ensure the quality and safety of pharmaceutical products

Contamination control strategy (CCS) Annex 1

15 June 2023

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In the article written by Edmondo Masi, Senior GMP Consultant, the importance of strategic definition for contamination control (CCS – Contamination Control Strategy) and its connection to Annex 1 is discussed.

The CCS is defined in the Annex 1 document as a planned set of controls for microorganisms, endotoxins/pyrogens, and particles, gathered in a dossier, aimed at ensuring product quality and process performance.

It is a fundamental principle foreseen in Annex 1 that must be implemented in all manufacturing facilities.
The contamination control strategy dossier plays a crucial role in ensuring the quality and safety of pharmaceutical products, providing a comprehensive framework of implemented controls and monitoring measures to manage contamination risks.

Find out about the minimum content to foreseen in the CCS dossier and its relations within Annex 1.