The mass production of pharmaceuticals has significantly evolved since the industrial fabrication of synthetic drugs towards the end of the 19 th century 1 with efficient developments in process ...
A Contamination Control Strategy (CCS) identifies and evaluates contamination risks, explores mitigation options, and sets out plans for corrective and preventive actions. Its implementation addresses ...
A CCS is mandated by EU and US regulations and ICH guidelines to ensure product safety and compliance in pharmaceutical manufacturing. Key CCS elements include monitoring, validation, contamination ...
A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, ...
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