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About This Item

 

Full Description

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, well as incorporating additional retailer requirements. It refers to the requirements for good manufacturing practices (GMPs) applicable to all OTC drugs. It will assist in the determination of adequate facilities and controls for OTC drug manufacture with sufficient quality to ensure suitability for intended use.
 

Document History

  1. NSF/ANSI 455-4-2021


    Good Manufacturing Practices for Over-the-Counter Drugs

    • Most Recent
  2. NSF/ANSI 455-4-2020

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    Good Manufacturing Practices for Over-the-Counter Drugs

    • Historical Version
  3. NSF/ANSI 455-4-2018


    Good Manufacturing Practices for Over-the-Counter Drugs

    • Historical Version