21 CFR Part 211 - Current Good Manufacturing Practice
Records and Reports

21 CFR Part 211 - Current Good Manufacturing Practice 211.192: Production Record Review

Production and control records must be reviewed by the quality control unit before any batch is released or distributed. Discrepancies must be investigated whether or not the batch is already distributed.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • 58.185 Reporting of Nonclinical Laboratory Study Results

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Records and Reports

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.