21 CFR 111.315 - What are the requirements for laboratory control processes?
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.