21 CFR Part 211 - Current Good Manufacturing Practice
Control of Components

21 CFR Part 211 - Current Good Manufacturing Practice 211.84: Testing and Approval of Components

Each lot of components, drug product containers, and closures must be withheld from use until sampled, tested, and released by the quality control unit.

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

What else in your programme already covers this

This control maps to 2 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.

  • 58.105 Test and Control Article Characterization
  • 58.83 Reagents and Solutions

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.

Query this from an agent

The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.