Particle Monitoring Requirements: Pharmaceutical Cleanrooms
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.
Interested in learning more? Complete the form on this page to receive a free copy of the application note.