Regulatory & Industry Guidance

Heating, Ventilation, and Air Conditioning (HVAC) | IVT

I. Introduction   For Pharmaceutical/Bio-Pharmaceutical or Vaccines products manufactured under a cGMP [Current Good Manufacturing Practice ]environment, the intent of the Heating, Vent and Air Conditioning handbook is to outline the major regulatory guidelines by FDA [United States Food and Drug Administration], EMA [European Medicines Agencies] and/or other regulatory agencies.  Moreover, the topic of discussions will include recommendations from the subject matter expert including examples of warning letters/citations, and advice on avoiding the warning letters/citations relating to...

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