21 CFR 211.192
§ 211.192 Production record review.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 211.192, § 211.192 Production record review, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85994
- Permanent ID
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Full text
All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and followup.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.