21 CFR § 211.105 - Equipment identification.

---
identifier: "/us/cfr/t21/s211.105"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 211.105 - Equipment identification."
title_number: 21
title_name: "Food and Drugs"
section_number: "211.105"
section_name: "Equipment identification."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "211"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 355, 360b, 360ddd, 360ddd-1, 371, 374; 42 U.S.C. 216, 262, 263a, 264."
regulatory_source: "43 FR 45077, Sept. 29, 1978, unless otherwise noted."
cfr_part: "211"
---


# 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.