21 CFR 211.105
§ 211.105 Equipment identification.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 211.105, § 211.105 Equipment identification, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85965
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.