What is the role of testing in the new FDA GMPs for dietary supplements?
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 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, ens
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