Facts about Environmental Isolates and Growth Promotion Test

摘要

Pharmaceutical companies have been engaging the use of environmental isolates (El) for tests for media growth promotion. Currently, Regulatory Authorities expect evidence of the use of El in growth promotion testing (GPT). Regulatory enforcement of these expectations often resulted in observations from health authorities around the world. FDA Guidance for Industry for Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice (September 2004) says "The QC laboratory should determine if USP indicator organisms sufficiently represent production-related isolates. Environmental monitoring and sterility test isolates can be substituted (as appropriate) or added to the growth promotion challenge. FDA Guidance for Industry concerning Validation of Growth Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products (draft guidance, February, 2008) suggests in relation to selecting a panel of appropriate challenge microorganisms for validating an RMM, the inclusion of "isolates detected in starting materials, isolates detected by in-process testing or during preliminary product testing, isolates detected by environmental monitoring of your facility, [and] isolates from your production areas which represent low nutrient or high stress environments..."