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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.
- Published:
- 2018
- ANSI:
- ANSI Approved
- Number of Pages:
- 44
- File Size:
- 1 file , 880 KB