Disinfectant Validation: A Roadmap For Regulatory Compliance

By Carol A. Burnett, Jim Polarine, Jr., Elaine Kopis Sartain, and David J Shields.

The U.S. FDA (United States Food and Drug Administration), MHRA (Medicines and Healthcare products Regulatory Agency), HPRA (Health Products Regulatory Authority) and CFDA (China Food and Drug Administration), amongst others, routinely make observations about disinfectant validation studies and disinfectant practices. The U.S. FDA Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing (Aseptic Processing Guide September 2004) states “Each manufacturer must have a formal program governing the qualification, use and disposal of disinfectants.”  The current United States Pharmacopeia, USP 37 <1072> chapter gives some guidance on selection, use and qualification of disinfectants .  There is no question that drug manufacturers should provide evidence that room decontamination programs achieve and maintain desired contamination control levels. This paper will provide considerations and discuss best practices for validating disinfectants used in drug manufacturing areas.