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 25 controls organised across 7 domains, and applies in the United States.
How 21 CFR Part 58 - Good Laboratory Practice (GLP) maps to other frameworks
All 25 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 7 domains 21 CFR Part 58 - Good Laboratory Practice (GLP) groups its controls into
Frameworks that share controls with 21 CFR Part 58 - Good Laboratory Practice (GLP)
Each of these has at least one control mapped to a control in 21 CFR Part 58 - Good Laboratory Practice (GLP). The number is how many 21 CFR Part 58 - Good Laboratory Practice (GLP) controls are shared, counted from the mapping graph.
21 CFR Part 211 - Current Good Manufacturing Practice
21 shared controlsUK Gambling Commission - Cyber Resilience Requirements
1 shared controlTISAX - Trusted Information Security Assessment Exchange
1 shared controlProtective Security Policy Framework (PSPF) Release 2024
1 shared controlNIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
1 shared controlNIST Privacy Framework
1 shared controlNIS2 Directive Implementing Acts
1 shared controlNAIC Insurance Data Security Model Law (MDL-668)
1 shared controlTraining on frameworks that overlap 21 CFR Part 58 - Good Laboratory Practice (GLP)
There is no course on 21 CFR Part 58 - Good Laboratory Practice (GLP) 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 58 - Good Laboratory Practice (GLP) overlaps with the standards you already hold
What an auditor will ask you for
All 32 21 CFR Part 58 - Good Laboratory Practice (GLP) 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 58 - Good Laboratory Practice (GLP) evidence request listWhat 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?
How many controls does 21 CFR Part 58 - Good Laboratory Practice have?
Where does 21 CFR Part 58 - Good Laboratory Practice apply?
What frameworks does 21 CFR Part 58 - Good Laboratory Practice map to?
How do I get started with 21 CFR Part 58 - Good Laboratory Practice compliance?
Query 21 CFR Part 58 - Good Laboratory Practice (GLP) programmatically
21 CFR Part 58 - Good Laboratory Practice (GLP), its 25 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
How ready are you for 21 CFR Part 58 - Good Laboratory Practice (GLP)?
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