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    FDA and EU GMP Annex 1 Differences in Cleanroom Specifications

    Based on a presentation at Interphex in April 2019, 1 this article discusses the contradictions between the US and EU requirements for cleanroom Good Manufacturing Practices (GMPs). The author discusses particle concentration for cleanrooms “at rest,” particle contamination in the air, start-up testing vs. routine monitoring, risk analysis and “interlocking” doors. The author concludes that there should be globally harmonized GMP norms for cleanroom operation based on “ha...