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Full Description

The principles outlined in this Standard provide a comprehensive basis for the quality management system used in the manufacture of over-the-counter (OTC) drugs. Implementation of these principles shall result in the achievement of three main objectives:
  • achieve OTC drug realization: the organization shall implement and maintain a system that delivers OTC drugs with the quality attributes necessary to meet the requirements and expectations of customers, retailers, and regulatory authorities;
  • establish and maintain a state of control: the organization shall ensure the manufacture and supply of OTC drugs is in accordance with this Standard, thus providing customers with some assurance of continued suitability and reliability of supply; and
  • facilitate continual improvement: the organization shall collect objective evidence to continually develop and enhance the application of these quality management system principles to further assure OTC drug consistency.
 

Document History

  1. NSF/ANSI 455-4-2022


    Good Manufacturing Practices for Over-the-Counter Drugs

    • Most Recent
  2. NSF/ANSI 455-4-2021


    Good Manufacturing Practices for Over-the-Counter Drugs

    • Historical Version
  3. NSF/ANSI 455-4-2020


    Good Manufacturing Practices for Over-the-Counter Drugs

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

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    Good Manufacturing Practices for Over-the-Counter Drugs

    • Historical Version