CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (parts 100 to 191) > PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS > SUBPART J—Production and Process Control System: Requirements for Laboratory Operations (§111.303 to §111.325) > 111.315—What are the requirements for laboratory control processes?

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.