NSF/ANSI 455-4:2022
Current
The latest, up-to-date edition.
Good Manufacturing Practices for Over-the-Counter Drugs
Hardcopy , PDF
English, Chinese
04-01-2023
This standard is intended to define a standardized approach for auditing to determine the level of compliance of OTC drug products to 21 C.F.R. Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General and 21 C.F.R. Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals, International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use (ICH) Quality Guidelines, 1, 7 and 10, as well as incorporating additional retailer requirements.
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