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.
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Framework Domains (14)
Disqualification of Testing Facilities (Subpart K)
| Code | Title |
|---|---|
| 58.200 | Purpose of Disqualification |
| 58.202 | Grounds for Disqualification |
| 58.206 | Final Order on Disqualification |
| 58.219 | Reinstatement of Disqualified Facility |
Equipment
| Code | Title |
|---|---|
| 58.61 | Equipment Design |
| 58.63 | Maintenance and Calibration of Equipment |
Equipment and Operations (Subparts D & E)
| Code | Title |
|---|---|
| 58.61 | Equipment Design |
| 58.63 | Maintenance and Calibration of Equipment |
| 58.81 | Standard Operating Procedures |
| 58.83 | Reagents and Solutions |
| 58.90 | Animal Care |
Facilities
| Code | Title |
|---|---|
| 58.41 | General Facility Requirements |
| 58.43 | Animal Care Facilities |
| 58.47 | Laboratory Operation Areas |
| 58.51 | Specimen and Data Storage Facilities |
Facilities (Subpart C)
| Code | Title |
|---|---|
| 58.41 | General Facility Requirements |
| 58.43 | Animal Care Facilities |
| 58.45 | Animal Supply Facilities |
| 58.47 | Laboratory Operation Areas |
| 58.49 | Laboratory Operation Areas |
| 58.51 | Specimen and Data Storage Facilities |
General Provisions (Subpart A)
| Code | Title |
|---|---|
| 58.1 | Scope |
| 58.10 | Applicability to Grants and Contracts |
| 58.15 | Inspection of Testing Facility |
| 58.3 | Definitions |
Organization and Personnel
| Code | Title |
|---|---|
| 58.29 | Personnel |
| 58.31 | Testing Facility Management |
| 58.33 | Study Director |
| 58.35 | Quality Assurance Unit |
Organization and Personnel (Subpart B)
| Code | Title |
|---|---|
| 58.29 | Personnel |
| 58.31 | Testing Facility Management |
| 58.33 | Study Director |
| 58.35 | Quality Assurance Unit |
Protocol and Conduct of Study
| Code | Title |
|---|---|
| 58.120 | Protocol |
| 58.130 | Conduct of a Nonclinical Laboratory Study |
Records and Reports
| Code | Title |
|---|---|
| 58.185 | Reporting of Nonclinical Laboratory Study Results |
| 58.190 | Storage and Retrieval of Records and Data |
| 58.195 | Retention of Records |
Records and Reports (Subpart J)
| Code | Title |
|---|---|
| 58.185 | Reporting of Nonclinical Laboratory Study Results |
| 58.190 | Storage and Retrieval of Records and Data |
| 58.195 | Retention of Records |
Test Articles and Protocol (Subparts F & G)
| Code | Title |
|---|---|
| 58.105 | Test and Control Article Characterization |
| 58.107 | Test and Control Article Handling |
| 58.113 | Mixtures of Articles with Carriers |
| 58.120 | Protocol |
| 58.130 | Conduct of a Nonclinical Laboratory Study |
Test and Control Articles
| Code | Title |
|---|---|
| 58.105 | Test and Control Article Characterization |
| 58.107 | Test and Control Article Handling |
| 58.113 | Mixtures of Articles with Carriers |
Testing Facilities Operation
| Code | Title |
|---|---|
| 58.81 | Standard Operating Procedures |
| 58.83 | Reagents and Solutions |
| 58.90 | Animal Care |
Your Compliance Coverage
If you comply with 21 CFR Part 58 — Good Laboratory Practice (GLP), you already cover:
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
13%
4 controls mapped
Compare →CIS Controls v8
13%
4 controls mapped
Compare →NIS2 Directive Implementing Acts
13%
4 controls mapped
Compare →+ 449 more: UK Telecommunications (Security) Act 2021 (13%), ISO/IEC 27011:2024 (10%)
See all 452 mapped frameworks ↓Maps to 452 other frameworks
Frequently Asked Questions
What is 21 CFR Part 58 — Good Laboratory Practice (GLP)?
21 CFR Part 58 — Good Laboratory Practice (GLP) is a compliance framework from United States with 14 domains and 52 controls. 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 is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does 21 CFR Part 58 — Good Laboratory Practice (GLP) have?
21 CFR Part 58 — Good Laboratory Practice (GLP) has 52 controls organised across 14 domains. The largest domains are Facilities (Subpart C) (6 controls), Equipment and Operations (Subparts D & E) (5 controls), Test Articles and Protocol (Subparts F & G) (5 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does 21 CFR Part 58 — Good Laboratory Practice (GLP) map to?
21 CFR Part 58 — Good Laboratory Practice (GLP) maps to 452 other compliance frameworks. The top mapping partners are NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements (13% coverage), CIS Controls v8 (13% coverage), NIS2 Directive Implementing Acts (13% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with 21 CFR Part 58 — Good Laboratory Practice (GLP) compliance?
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