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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 microcontamination requirements of pharmaceutical manufacturing, defines a clean manufacturing environment, and shows how to prove contamination control over an environment.

Why Do I Need a Particle Counter?

All drugs must be formulated, filled, and finished in accordance with the current Good Manufacturing Practice (cGMP) regulations which state that cleanroom validation must be performed and impose limitations for production environments. In the United States these regulations are governed by the Food and Drug Administration (FDA) as the 21st Code of the Federal Register1. In Europe the EC guidelines for product manufacture must be met and the specificity of the drug product defines which Annex2 is pertinent for the type of drug produced. The pharmaceutical company manufacturing the product must, therefore, prove that they have been in compliance with the regulations relative to environmental controls at every stage prior to a product’s release to market and ultimately the patient.

The US cGMP regulations govern various drugs manufacture activities including:

• Organization and Personnel [21 CFR 211 Subpart B]

• Buildings and Facilities [21 CFR 211 Subpart C]

• Production and Process Controls [21 CFR 211 Subpart F]

Click here to download the full paper: Click here to signup and download files (Particle Counters for Cleanroom Monitoring and Certification)