GMP Manufacturing of Dietary Supplements
Not everyone in the dietary supplement business is aware that the FDA now requires Good Manufacturing Practices (GMPs) in manufacturing, packaging, labeling, or holding operations for dietary supplements. Any company involved has to establish and to follow cGMPs to ensure that packaging and labeling is done as specified in the master manufacturing record and to ensure the quality of the product that reaches the market. Practitioners such as herbalists, acupuncturists, naturopaths, and other related health care providers are subject to the cGMP rule. Failure to comply means the FDA will consider your products to be adulterated.
The FDA has been inspecting manufactures of dietary supplements and companies that are “own-label” dietary supplement including distributors of botanical dietary supplements and vitamin/mineral dietary supplements. They audit for GMP compliance and quality by which they mean “that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration. The main tenants of GMPs include tracking batches from beginning to end and documenting under what conditions, with whom, and what materials (and where they were obtained) the batch was produced under.
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