---
kind: "section"
citation: "21 C.F.R. § 211.105"
title: "21"
number: "211.105"
heading: "Equipment identification."
url: "https://uscodex.org/cfr/21/211.105"
---

# §211.105. Equipment identification.

- (a) All compounding and storage containers, processing lines, and major equipment used during the production of a batch of a drug product shall be properly identified at all times to indicate their contents and, when necessary, the phase of processing of the batch.
- (b) Major equipment shall be identified by a distinctive identification number or code that shall be recorded in the batch production record to show the specific equipment used in the manufacture of each batch of a drug product. In cases where only one of a particular type of equipment exists in a manufacturing facility, the name of the equipment may be used in lieu of a distinctive identification number or code.

## Notes

### Authority

Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 360ddd, 360ddd-1, 371, 374; 42 U.S.C. 216, 262, 263a, 264.

### Source

Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.