Yes, the final FDA GMPs requires you to verify that every finished batch of dietary supplement meets each product specification for identity, purity, strength, composition and for limits on contamination that may adulterate your product. Specifically, under 21 CFR 111.75(c) and (d), you must select and test or examine one or more established finished product specifications (for identity, purity, strength, composition, and limits on contaminants that may adulterate your product) to verify that your manufacturing process has yielded a finished batch that meets all product specification except those exempted by quality control personnel under §111.75(d). You also must provide adequate documentation for why meeting these specifications will ensure your finished batch meets all product specifications and quality control personnel must review and approve such documentation.
The rule provides some flexibility in this area, requiring testing of every finished batch or alternatively, allowing for testing a subset of batches identified using a sound statistical sampling plan. The rule also allows you to exempt one or more product specifications from the verification (testing or examination) requirements if you determine and document that the specification cannot verified through testing because there is no scientifically valid method for testing the exempted product specification at the finished product stage and the specification can be verified through component and in-process testing or examination. Additionally, the rule allows you to select one, two, three or more specifications that could be used to demonstrate compliance with specifications if testing these specifications will verify that the other untested specifications are met. Once again, you must document your basis for why this is so and your quality control personnel must review and approve such documentation.
