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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
Compare 21 CFR Part 211 — Current Good Manufacturing Practice
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21 CFR Part 211 — Current Good Manufacturing Practice by Industry
21 CFR Part 211 — Current Good Manufacturing Practice for Healthcare→21 CFR Part 211 — Current Good Manufacturing Practice for Financial Services→21 CFR Part 211 — Current Good Manufacturing Practice for Technology→21 CFR Part 211 — Current Good Manufacturing Practice for Government→21 CFR Part 211 — Current Good Manufacturing Practice for Manufacturing→21 CFR Part 211 — Current Good Manufacturing Practice for Energy→21 CFR Part 211 — Current Good Manufacturing Practice for Retail→21 CFR Part 211 — Current Good Manufacturing Practice for Education→
21 CFR Part 211 — Current Good Manufacturing Practice by Role
21 CFR Part 211 — Current Good Manufacturing Practice for CISOs→21 CFR Part 211 — Current Good Manufacturing Practice for Compliance Officers→21 CFR Part 211 — Current Good Manufacturing Practice for Risk Managers→21 CFR Part 211 — Current Good Manufacturing Practice for IT Directors→21 CFR Part 211 — Current Good Manufacturing Practice for DPOs→21 CFR Part 211 — Current Good Manufacturing Practice for Auditors→
Frequently Asked Questions
What is 21 CFR Part 211?
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.
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.
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