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Code of Federal Regulations Title 21. Food and Drugs § 21.111.315 What are the requirements for laboratory control processes?

Current as of January 02, 2025 | Updated by Findlaw Staff

You must establish and follow laboratory control processes that are reviewed and approved by quality control personnel, including the following:

(a) Use of criteria for establishing appropriate specifications;

(b) Use of sampling plans for obtaining representative samples, in accordance with subpart E of this part, of:

(1) Components, packaging, and labels;

(2) In-process materials;

(3) Finished batches of dietary supplements;

(4) Product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier);  and

(5) Packaged and labeled dietary supplements.

(c) Use of criteria for selecting appropriate examination and testing methods;

(d) Use of criteria for selecting standard reference materials used in performing tests and examinations;  and

(e) Use of test methods and examinations in accordance with established criteria.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.111.315 What are the requirements for laboratory control processes? - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-111-315/

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