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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..
Domains
Records and Reports
Protocol and Conduct of Study
Test and Control Articles
Testing Facilities Operation
Equipment
Compare 21 CFR Part 58 - Good Laboratory Practice (GLP)
21 CFR Part 58 - Good Laboratory Practice (GLP) vs ISO 27001:2022View comparison →21 CFR Part 58 - Good Laboratory Practice (GLP) vs SOC 2View comparison →21 CFR Part 58 - Good Laboratory Practice (GLP) vs NIST CSF 2.0View comparison →21 CFR Part 58 - Good Laboratory Practice (GLP) vs GDPRView comparison →21 CFR Part 58 - Good Laboratory Practice (GLP) vs HIPAAView comparison →21 CFR Part 58 - Good Laboratory Practice (GLP) vs PCI DSS 4.0View comparison →
21 CFR Part 58 - Good Laboratory Practice (GLP) by Industry
21 CFR Part 58 - Good Laboratory Practice (GLP) for Healthcare→21 CFR Part 58 - Good Laboratory Practice (GLP) for Financial Services→21 CFR Part 58 - Good Laboratory Practice (GLP) for Technology→21 CFR Part 58 - Good Laboratory Practice (GLP) for Government→21 CFR Part 58 - Good Laboratory Practice (GLP) for Manufacturing→21 CFR Part 58 - Good Laboratory Practice (GLP) for Energy→21 CFR Part 58 - Good Laboratory Practice (GLP) for Retail→21 CFR Part 58 - Good Laboratory Practice (GLP) for Education→
21 CFR Part 58 - Good Laboratory Practice (GLP) by Role
21 CFR Part 58 - Good Laboratory Practice (GLP) for CISOs→21 CFR Part 58 - Good Laboratory Practice (GLP) for Compliance Officers→21 CFR Part 58 - Good Laboratory Practice (GLP) for Risk Managers→21 CFR Part 58 - Good Laboratory Practice (GLP) for IT Directors→21 CFR Part 58 - Good Laboratory Practice (GLP) for DPOs→21 CFR Part 58 - Good Laboratory Practice (GLP) for Auditors→
Frequently Asked Questions
What is 21 CFR Part 58 - Good Laboratory Practice?
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..
How many controls does 21 CFR Part 58 - Good Laboratory Practice have?
21 CFR Part 58 - Good Laboratory Practice contains 31 controls organized across 14 domains.
Where does 21 CFR Part 58 - Good Laboratory Practice apply?
21 CFR Part 58 - Good Laboratory 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 58 - Good Laboratory Practice map to?
21 CFR Part 58 - Good Laboratory Practice has control-to-control mappings with 182 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.
How do I get started with 21 CFR Part 58 - Good Laboratory 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.
How ready are you for 21 CFR Part 58 - Good Laboratory Practice (GLP)?
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