21 CFR Part 211 - Current Good Manufacturing Practice
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. It comprises 76 controls organised across 20 domains, and applies in the United States.
How 21 CFR Part 211 - Current Good Manufacturing Practice maps to other frameworks
All 76 controls, each one mapped to the equivalent requirement in other standards, with the evidence that carries across and the mappings that were judged and rejected shown alongside. No account needed to look.
See the control mappings →The 20 domains 21 CFR Part 211 - Current Good Manufacturing Practice groups its controls into
Frameworks that share controls with 21 CFR Part 211 - Current Good Manufacturing Practice
Each of these has at least one control mapped to a control in 21 CFR Part 211 - Current Good Manufacturing Practice. The number is how many 21 CFR Part 211 - Current Good Manufacturing Practice controls are shared, counted from the mapping graph.
21 CFR Part 58 - Good Laboratory Practice (GLP)
12 shared controlsFDA Quality Management System Regulation (QMSR)
7 shared controlsProtective Security Policy Framework (PSPF) Release 2024
4 shared controlsIEEE 1686
4 shared controlsIEC 62443
4 shared controlsNIST SP 800-53 Rev 5
4 shared controlsISO 27019
4 shared controlsNIST SP 1800-32
4 shared controlsImplementation guides for frameworks that overlap 21 CFR Part 211 - Current Good Manufacturing Practice
Training on frameworks that overlap 21 CFR Part 211 - Current Good Manufacturing Practice
There is no course on 21 CFR Part 211 - Current Good Manufacturing Practice itself. These cover frameworks that share controls with it, so the material carries across even though the standard named is different.
Where 21 CFR Part 211 - Current Good Manufacturing Practice overlaps with the standards you already hold
What an auditor will ask you for
All 78 21 CFR Part 211 - Current Good Manufacturing Practice controls, each with what it requires, the artefacts an auditor will ask you for, and where it commonly fails. Free to read, nothing to fill in.
Read the 21 CFR Part 211 - Current Good Manufacturing Practice evidence request listWhat 21 CFR Part 211 - Current Good Manufacturing Practice means in your sector
What 21 CFR Part 211 - Current Good Manufacturing Practice means for your job
Questions people ask about 21 CFR Part 211 - Current Good Manufacturing Practice
What is 21 CFR Part 211 - Current Good Manufacturing Practice?
How many controls does 21 CFR Part 211 - Current Good Manufacturing Practice have?
Where does 21 CFR Part 211 - Current Good Manufacturing Practice apply?
What frameworks does 21 CFR Part 211 - Current Good Manufacturing Practice map to?
How do I get started with 21 CFR Part 211 - Current Good Manufacturing Practice compliance?
Query 21 CFR Part 211 - Current Good Manufacturing Practice programmatically
21 CFR Part 211 - Current Good Manufacturing Practice, its 76 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
21 CFR Part 211 - Current Good Manufacturing Practice API reference and MCP config →What 21 CFR Part 211 - Current Good Manufacturing Practice requires, control by control
Each page carries the requirement text for one 21 CFR Part 211 - Current Good Manufacturing Practice control and what an assessor expects to see as evidence.
- 211-100 Written Procedures for Production and Process Control
- 211-122 Materials Examination and Usage Criteria
- 211-142 Warehousing Procedures
- 211-180 General Records Requirements
- 211-192 Production Record Review
- 211-22 Responsibilities of Quality Control Unit
- 211-25 Personnel Qualifications
- 211-28 Personnel Responsibilities and Hygiene
- 211-42 Design and Construction of Buildings
- 211-67 Equipment Cleaning and Maintenance
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