How to ensure the quality and safety of pharmaceutical products
15 June 2023
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.