21 CFR 213.192
§ 213.192 Production record review.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 213.192, § 213.192 Production record review, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86071
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Full text
(a) Manufacturing production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality unit to determine compliance with all established, approved written procedures before a batch is released or distributed. The quality unit must review production records to determine whether errors or unexplained discrepancies have occurred prior to batch release. If errors or unexplained discrepancies have occurred, or a batch or any component of the batch fails to meet any of its specifications, the firm must thoroughly investigate and take appropriate corrective actions. A written record of the investigation shall be made and shall include the conclusions and followup.
(b) For production and control records of filling at a delivery site, quality unit review as described in paragraph (a) of this section shall be within one business day after fill.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.