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.