How many controls does 21 CFR Part 211 have?

21 CFR Part 211 contains 57 controls organized across 11 domains.

Where does 21 CFR Part 211 apply?

21 CFR Part 211 is applicable in United States. Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.

What frameworks does 21 CFR Part 211 map to?

21 CFR Part 211 has control-to-control mappings with 411 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.

How do I get started with 21 CFR Part 211 compliance?

Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.

21 CFR Part 211 — Current Good Manufacturing Practice

Title 21 Code of Federal Regulations Part 211 establishes the minimum current good manufacturing practice (cGMP) requirements for the preparation of drug products (finished pharmaceuticals) for administration to humans or animals. Covers all aspects of pharmaceutical manufacturing from personnel and facilities to production controls and record keeping.

Domains

Subpart H — Holding and Distribution

Subpart G — Packaging and Labeling Control

Subpart K — Returned and Salvaged Drug Products

Subpart F — Production and Process Controls

Subpart B — Organization and Personnel

Frequently Asked Questions

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