We believe FDA was responsive to the many industry comments submitted in response to the proposed FDA GMPs in 2003 objecting to the heavy emphasis on finished product testing, especially the requirements for testing every batch of finished dietary supplements for identity, quality, strength, purity and composition; the understanding being that you cannot test quality into the product at the end. The agency has modified the testing requirements in the final rule, providing more flexibility and reducing the finished product testing burden, making it more consistent with current quality systems principles, which uses testing as an element of quality control, not the central focus or tool to ensuring quality. Basically, in the final CGMPs, the role of testing is to verify compliance to specifications set by the manufacturer and confirm that the manufacturing processes are sufficiently controlled to prevent adulteration. 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 GMPs 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 was not unintentionally contaminated or adulterated during its manufacture.
