Dietary supplements, or nutraceuticals are regulated  by the FDA under the Federal Food Drug and Cosmetic Act of 1938 amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA)  to contain specific provisions regarding dietary supplements and dietary ingredients. DSHEA granted FDA the authority to establish good manufacturing practice (GMP) regulations. DSHEA states: “these regulations are to be modeled after” current good manufacturing practice regulations in effect for the rest of the food industry. FDA cGMP regulations exist for drugs, medical devices, foods, with proposed GMP regulations for dietary supplements. In the preamble, the FDA states:

• Consistent with basic cGMP principles, ensuring the quality of the dietary supplement product requires that the manufacturer establish precisely what it will produce (specifications for its product), how it will make the product (processes), and which process controls and tests it will use to ensure reliable, reproducible results. 21 CFR 111 Preamble (page 113)

• Under the final FDA cGMPs for dietary supplements, testing and/or examinations are used to confirm incoming components and in-process materials meet their specifications. Additionally, testing and examination are required to ensure that the manufacturing processes were sufficiently controlled to ensure that the finished product meets its specifications and are not unintentionally contaminated or adulterated during its manufacture

It is critical that the owner has their Levels of documentation such as; Mission statement, policies, SOPs, work instructions, quality records, in place. As they plan to move forward on the design of a manufacturing facility.

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