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NSF/ANSI 455-4-2022

Good Manufacturing Practices for Over-the-Counter Drugs

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 and 21 CFR Part 211, 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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