NSF/ANSI 455-4:2021
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Good Manufacturing Practices for Over-the-Counter Drugs
Hardcopy , PDF
05-03-2023
English
12-01-2021
This standard is intended to define a standardized approach for auditing to determine the level of compliance of over-the-counter (OTC) drug products to 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General and 21 CFR 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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