How many controls does 21 CFR Part 58 have?

21 CFR Part 58 contains 31 controls organized across 7 domains.

Where does 21 CFR Part 58 apply?

21 CFR Part 58 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 map to?

21 CFR Part 58 has control-to-control mappings with 32 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 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.

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

Disqualification of Testing Facilities (Subpart K)

Records and Reports (Subpart J)

Test Articles and Protocol (Subparts F & G)

Equipment and Operations (Subparts D & E)

Facilities (Subpart C)

Frequently Asked Questions

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