---
kind: "section"
citation: "21 C.F.R. § 111.60"
title: "21"
number: "111.60"
heading: "What are the design requirements for the production and process control system?"
url: "https://uscodex.org/cfr/21/111.60"
---

# §111.60. What are the design requirements for the production and process control system?

- (a) Your production and in-process control system must be designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and
- (b) The production and in-process control system must include all requirements of subparts E through L of this part and must be reviewed and approved by quality control personnel.

## 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.