Particle Monitoring Requirements: Pharmaceutical Cleanrooms

Abstract

All drug products must be manufactured in accordance with the current Good Manufacturing Practice (cGMP) regulations of the country of manufacture or the country/region of export. Pharmaceutical manufacturers must demonstrate compliance with the regulations at every stage before a drug can be released to market. This paper explains the various environmental micro-contamination requirements of pharmaceutical manufacturing, defines a clean manufacturing environment, and shows how to prove contamination control over an environment.

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