21 CFR 211.182
§ 211.182 Equipment cleaning and use log.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 211.182, § 211.182 Equipment cleaning and use log, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85990
- Permanent ID
ys:prov:85990@1- SHA-256
ac5a5eed56baf5b4c9c27032c3f0850b01dabfbe3ceacc3d7438f840990b1a57
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance (or, if the cleaning and maintenance is performed using automated equipment under § 211.68, just the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.