§ 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.