21 CFR Part 211 - Current Good Manufacturing Practice
Organization and Personnel

21 CFR Part 211 - Current Good Manufacturing Practice 211.22: Responsibilities of Quality Control Unit

A quality control unit must exist with authority and responsibility to approve or reject components, in-process materials, packaging, labeling, and finished products. Written procedures must define its responsibilities.

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

What else in your programme already covers this

This control maps to 4 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.

  • 58.15 Inspection of Testing Facility
  • 58.31 Testing Facility Management
  • 58.33 Study Director
  • 58.35 Quality Assurance Unit

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.

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