21 CFR Part 211 - Current Good Manufacturing Practice
Production and Process Controls

21 CFR Part 211 - Current Good Manufacturing Practice 211.100: Written Procedures for Production and Process Control

Written procedures for production and process control must be designed to assure drug products have identity, strength, quality, and purity they purport to possess. Deviations must be documented.

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

What else in your programme already covers this

This control maps to 3 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.

  • 58.120 Protocol
  • 58.130 Conduct of a Nonclinical Laboratory Study
  • 58.81 Standard Operating Procedures

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 Production and Process Controls

Query this from an agent

The graph holds this control, the 3 it maps to, and the evidence behind each claim, over MCP and REST.