---
kind: "section"
citation: "21 C.F.R. § 111.315"
title: "21"
number: "111.315"
heading: "What are the requirements for laboratory control processes?"
url: "https://uscodex.org/cfr/21/111.315"
---

# §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.**

## Notes

### Authority

Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.

### Source

Source: 72 FR 34942, June 25, 2007, unless otherwise noted.