Good Manufacturing Practices for Dietary Supplements
|Publication Date:||6 April 2020|
This Standard is intended to define a standardized approach for auditing to determine the level of compliance of dietary supplement products to 21 CFR Part 111, Current Good Manufacturing Practices (GMPs) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as well as incorporating additional retailer requirements. It refers to the requirements for GMP applicable to all dietary supplements. It will assist in the determination of adequate facilities and controls for dietary supplement manufacture with sufficient quality to ensure suitability for intended use.
The principles outlined in this Standard provide a comprehensive basis for the quality management system used in the manufacture of dietary supplements. Implementation of these principles shall result in the achievement of three main objectives:
- achieve dietary supplement realization: The organization shall implement and maintain a system that delivers dietary supplements 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 dietary supplements 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 dietary supplements consistency.