---
kind: "section"
citation: "21 C.F.R. § 111.30"
title: "21"
number: "111.30"
heading: "What requirements apply to automated, mechanical, or electronic equipment?"
url: "https://uscodex.org/cfr/21/111.30"
---

# §111.30. What requirements apply to automated, mechanical, or electronic equipment?


For any automated, mechanical, or electronic equipment that you use to manufacture, package, label, or hold a dietary supplement, you must:

- (a) Design or select equipment to ensure that dietary supplement specifications are consistently met;
- (b) Determine the suitability of the equipment by ensuring that your equipment is capable of operating satisfactorily within the operating limits required by the process;
- (c) **Routinely calibrate, inspect, or check the equipment to ensure proper performance.** Your quality control personnel must periodically review these calibrations, inspections, or checks;
- (d) Establish and use appropriate controls for automated, mechanical, and electronic equipment (including software for a computer controlled process) to ensure that any changes to the manufacturing, packaging, labeling, holding, or other operations are approved by quality control personnel and instituted only by authorized personnel; and
- (e) Establish and use appropriate controls to ensure that the equipment functions in accordance with its intended use. These controls must be 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.