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GMP Compliance

GMP

The GMP Certification Program is designed to verify compliance of suppliers of dietary supplements with a standardized set of good manufacturing practices (GMP) developed by FDA. (Cood Manufacturing Practices) per section 520 of the Food, Drug and Cosmetic (FD&C) Act, requires that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, of dietary supplements and nutraceuticals intended for commercial distribution in the United States. This program is based upon authorized third party inspections and comprehensive audits of GMP programs in the areas of Personnel, Plant and Grounds, Sanitation, Equipment, Quality Operations, Production and Process Controls, and Warehouse, Distribution, and Post-Distribution Practices. This program ensures that all elements of the manufacturing process are reviewed to provide reasonable assurance that processes are sufficiently controlled, implemented and maintained so that products meet their expressed quality and safety.

An inspection includes a complete program review and performance evaluation. The evaluation is based on conformance with the GMP standards established by the U. S. Department of Health and Human Services, Food and Drug Administration (FDA), and Center for Food Safety and Applied Nutrition (CFSAN).

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Date of Last Modification: Oct 31st, 2017