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Contamination Control Strategy

Meaning

A Contamination Control Strategy is a formally documented, risk-based program designed to proactively prevent, effectively detect, and rigorously control the introduction of any unintended biological, chemical, or particulate matter into a manufacturing process. This strategy is mandatory within the pharmaceutical and compounding industries to ensure the absolute purity and sterility of medicinal products. For injectable hormonal preparations, this framework is a critical safeguard against patient harm. It assures that the final product meets stringent quality attributes.