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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
Returned and Salvaged Drug Products
Records and Reports
Laboratory Controls
Holding and Distribution
Packaging and Labeling Control
Compare 21 CFR Part 211 - Current Good Manufacturing Practice
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21 CFR Part 211 - Current Good Manufacturing Practice by Industry
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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 - 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.
How many controls does 21 CFR Part 211 - Current Good Manufacturing Practice have?
21 CFR Part 211 - Current Good Manufacturing Practice contains 78 controls organized across 21 domains.
Where does 21 CFR Part 211 - Current Good Manufacturing Practice apply?
21 CFR Part 211 - Current Good Manufacturing Practice 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 - Current Good Manufacturing Practice map to?
21 CFR Part 211 - Current Good Manufacturing Practice has control-to-control mappings with 198 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 - Current Good Manufacturing Practice 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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