21 CFR Part 58 - Good Laboratory Practice (GLP)
What is 21 CFR Part 58 - Good Laboratory Practice (GLP)?
Title 21 Code of Federal Regulations Part 58 establishes Good Laboratory Practice (GLP) regulations for nonclinical laboratory studies supporting applications for research or marketing permits for FDA-regulated products. Covers organization, facilities, equipment, testing operations, records, and reporting requirements to ensure the quality and integrity of safety data.. It comprises 31 controls organised across 14 domains, and applies in the United States.
How 21 CFR Part 58 - Good Laboratory Practice (GLP) maps to other frameworks
All 31 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 14 domains 21 CFR Part 58 - Good Laboratory Practice (GLP) groups its controls into
Where 21 CFR Part 58 - Good Laboratory Practice (GLP) overlaps with the standards you already hold
What 21 CFR Part 58 - Good Laboratory Practice (GLP) means in your sector
What 21 CFR Part 58 - Good Laboratory Practice (GLP) means for your job
Questions people ask about 21 CFR Part 58 - Good Laboratory Practice (GLP)
What is 21 CFR Part 58 - Good Laboratory Practice?
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Query 21 CFR Part 58 - Good Laboratory Practice (GLP) programmatically
21 CFR Part 58 - Good Laboratory Practice (GLP), its 31 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 58 - Good Laboratory Practice (GLP) API reference and MCP config →What 21 CFR Part 58 - Good Laboratory Practice (GLP) requires, control by control
Each page carries the requirement text for one 21 CFR Part 58 - Good Laboratory Practice (GLP) control and what an assessor expects to see as evidence.
- 58-105 Test and Control Article Characterization
- 58-107 Test and Control Article Handling
- 58-120 Protocol
- 58-130 Conduct of a Nonclinical Laboratory Study
- 58-15 Inspection of Testing Facility
- 58-185 Reporting of Nonclinical Laboratory Study Results
- 58-190 Storage and Retrieval of Records and Data
- 58-195 Retention of Records
- 58-29 Personnel
- 58-31 Testing Facility Management
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