21 CFR 211.192 - Production record review.

§ 211.192 Production record review.
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.

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 211 after this date.

  • 2013-11-20; vol. 78 # 224 - Wednesday, November 20, 2013
    1. 78 FR 69604 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule; extension of comment period for the proposed rule and for its information collection provisions.
      The FDA is extending the comment period for the proposed rule referenced in the Summary. Submit either electronic or written comments on the notice of proposed rulemaking by November 22, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by November 22, 2013 (see the “Paperwork Reduction Act of 1995” section).
      21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211