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NSF/ANSI 455-4-2021

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 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.


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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