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21 CFR Part 58 - Good Laboratory Practice (GLP)
United States
vCurrent (as amended)
14 domains
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.
Verified
Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.
Framework Domains (14)
Disqualification of Testing Facilities (Subpart K)
4 controls
| 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
2 controls
| Code | Title |
|---|---|
| 58.61 | Equipment Design |
| 58.63 | Maintenance and Calibration of Equipment |
Equipment and Operations (Subparts D & E)
5 controls
| 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
4 controls
| 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)
6 controls
| 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)
4 controls
| Code | Title |
|---|---|
| 58.1 | Scope |
| 58.10 | Applicability to Grants and Contracts |
| 58.15 | Inspection of Testing Facility |
| 58.3 | Definitions |
Organization and Personnel
4 controls
| Code | Title |
|---|---|
| 58.29 | Personnel |
| 58.31 | Testing Facility Management |
| 58.33 | Study Director |
| 58.35 | Quality Assurance Unit |
Organization and Personnel (Subpart B)
4 controls
| Code | Title |
|---|---|
| 58.29 | Personnel |
| 58.31 | Testing Facility Management |
| 58.33 | Study Director |
| 58.35 | Quality Assurance Unit |
Protocol and Conduct of Study
2 controls
| Code | Title |
|---|---|
| 58.120 | Protocol |
| 58.130 | Conduct of a Nonclinical Laboratory Study |
Records and Reports
3 controls
| 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)
3 controls
| 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)
5 controls
| 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
3 controls
| 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
3 controls
| 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:
21 CFR Part 211 - Current Good Manufacturing Practice
74%
23 controls mapped
Compare →NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
13%
4 controls mapped
Compare →ISO/IEC 27011:2024
10%
3 controls mapped
Compare →+ 179 more: UK Gambling Commission - Cyber Resilience Requirements (10%), Protective Security Policy Framework (PSPF) Release 2024 (10%)
See all 182 mapped frameworks ↓Maps to 182 other frameworks
31 total controls
21 CFR Part 211 - Current Good Manufacturing Practice
23 source controls mapped|16 target controls covered
74%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
4 source controls mapped|7 target controls covered
13%
ISO/IEC 27011:2024
3 source controls mapped|5 target controls covered
10%
UK Gambling Commission - Cyber Resilience Requirements
3 source controls mapped|2 target controls covered
10%
Protective Security Policy Framework (PSPF) Release 2024
3 source controls mapped|2 target controls covered
10%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
3 source controls mapped|3 target controls covered
10%
ICAO Annex 17 - Aviation Security (AVSEC)
3 source controls mapped|2 target controls covered
10%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
3 source controls mapped|4 target controls covered
10%
FedRAMP Rev 5
3 source controls mapped|2 target controls covered
10%
ISO/IEC 27400:2022
3 source controls mapped|4 target controls covered
10%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
3 source controls mapped|2 target controls covered
10%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|3 target controls covered
10%
ISO 28001:2007 Supply Chain Security Management
3 source controls mapped|2 target controls covered
10%
SOC 2
3 source controls mapped|3 target controls covered
10%
SSAE 18 - Attestation Standards (SOC Reporting)
3 source controls mapped|3 target controls covered
10%
NIST Cybersecurity Framework 2.0
3 source controls mapped|3 target controls covered
10%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
3 source controls mapped|5 target controls covered
10%
ICH E6(R3) - Good Clinical Practice
3 source controls mapped|2 target controls covered
10%
FDA Quality Management System Regulation (QMSR)
3 source controls mapped|3 target controls covered
10%
BRCGS Global Standard for Food Safety Issue 9
3 source controls mapped|6 target controls covered
10%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
3 source controls mapped|9 target controls covered
10%
AS9100D - Aerospace Quality Management System
3 source controls mapped|2 target controls covered
10%
ISO/IEC 27003:2017
3 source controls mapped|2 target controls covered
10%
ISO/IEC 27006:2024
3 source controls mapped|6 target controls covered
10%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories
3 source controls mapped|6 target controls covered
10%
IEC 62304:2015 Medical Device Software Lifecycle Processes
3 source controls mapped|4 target controls covered
10%
ISO/IEC 25012:2008 - Data Quality Model
3 source controls mapped|3 target controls covered
10%
ISO 10006:2003
2 source controls mapped|2 target controls covered
6%
ISO 31000:2018
2 source controls mapped|2 target controls covered
6%
ISO/IEC 23894:2023
2 source controls mapped|3 target controls covered
6%
WCAG 2.2
2 source controls mapped|1 target controls covered
6%
W3C Verifiable Credentials (VC) Data Model 2.0
2 source controls mapped|1 target controls covered
6%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
2 source controls mapped|1 target controls covered
6%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
2 source controls mapped|1 target controls covered
6%
UK GDPR (UK General Data Protection Regulation)
2 source controls mapped|1 target controls covered
6%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
2 source controls mapped|1 target controls covered
6%
UK Bribery Act 2010
2 source controls mapped|1 target controls covered
6%
Trinidad and Tobago Data Protection Act 2011
2 source controls mapped|3 target controls covered
6%
TEFCA - Trusted Exchange Framework and Common Agreement
2 source controls mapped|1 target controls covered
6%
Tanzania Personal Data Protection Act (Draft)
2 source controls mapped|2 target controls covered
6%
SLSA
2 source controls mapped|1 target controls covered
6%
SIG (Shared Assessments)
2 source controls mapped|1 target controls covered
6%
Regulation on the European Health Data Space (EHDS)
2 source controls mapped|1 target controls covered
6%
PSD2 SCA
2 source controls mapped|1 target controls covered
6%
PTES
2 source controls mapped|1 target controls covered
6%
Philippines Cybercrime Prevention Act (RA 10175)
2 source controls mapped|1 target controls covered
6%
PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)
2 source controls mapped|2 target controls covered
6%
Pakistan Personal Data Protection Bill 2023
2 source controls mapped|2 target controls covered
6%
OWASP Top 10:2025
2 source controls mapped|1 target controls covered
6%
OWASP SAMM
2 source controls mapped|1 target controls covered
6%
OWASP MASVS
2 source controls mapped|1 target controls covered
6%
OWASP DevSecOps Maturity Model (DSOMM)
2 source controls mapped|2 target controls covered
6%
OWASP ASVS
2 source controls mapped|1 target controls covered
6%
OSFI B-13
2 source controls mapped|1 target controls covered
6%
OpenSSF Scorecard
2 source controls mapped|1 target controls covered
6%
Open Banking Security
2 source controls mapped|1 target controls covered
6%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
2 source controls mapped|1 target controls covered
6%
O-RAN WG11 Security Specification
2 source controls mapped|3 target controls covered
6%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
2 source controls mapped|2 target controls covered
6%
Notifiable Data Breaches Scheme (Australia)
2 source controls mapped|1 target controls covered
6%
NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
2 source controls mapped|2 target controls covered
6%
NIST SP 800-92
2 source controls mapped|1 target controls covered
6%
NIST SP 800-88
2 source controls mapped|1 target controls covered
6%
NIST SP 800-63-4
2 source controls mapped|1 target controls covered
6%
NIST SP 800-61
2 source controls mapped|1 target controls covered
6%
NIST SP 800-146
2 source controls mapped|1 target controls covered
6%
NIST SP 800-145
2 source controls mapped|1 target controls covered
6%
NIST SP 800-144
2 source controls mapped|1 target controls covered
6%
NIST SP 800-137
2 source controls mapped|1 target controls covered
6%
NIST SP 800-123
2 source controls mapped|1 target controls covered
6%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
2 source controls mapped|1 target controls covered
6%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
2 source controls mapped|1 target controls covered
6%
Nigeria Data Protection Act 2023 (NDPA)
2 source controls mapped|3 target controls covered
6%
Nebraska Data Privacy Act
2 source controls mapped|3 target controls covered
6%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
2 source controls mapped|2 target controls covered
6%
MTCS (Singapore)
2 source controls mapped|2 target controls covered
6%
Monetary Authority of Singapore Technology Risk Management Guidelines
2 source controls mapped|1 target controls covered
6%
MITRE D3FEND
2 source controls mapped|1 target controls covered
6%
MITRE ATT&CK
2 source controls mapped|1 target controls covered
6%
South Korea PIPA
2 source controls mapped|1 target controls covered
6%
ITU Radio Regulations and Space Security Standards
2 source controls mapped|1 target controls covered
6%
ITAR - International Traffic in Arms Regulations
2 source controls mapped|1 target controls covered
6%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
2 source controls mapped|1 target controls covered
6%
Israel Protection of Privacy Law (5741-1981)
2 source controls mapped|2 target controls covered
6%
ISMAP (Japan)
2 source controls mapped|1 target controls covered
6%
India Account Aggregator Framework (RBI)
2 source controls mapped|1 target controls covered
6%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
2 source controls mapped|1 target controls covered
6%
ICH Q10 - Pharmaceutical Quality System
2 source controls mapped|2 target controls covered
6%
IATF 16949:2016 - Quality Management System for Automotive Production
2 source controls mapped|2 target controls covered
6%
IATA Operational Safety Audit (IOSA) Standards Manual
2 source controls mapped|1 target controls covered
6%
HKMA SPM
2 source controls mapped|1 target controls covered
6%
HKMA Cyber Resilience Assessment Framework (C-RAF)
2 source controls mapped|1 target controls covered
6%
GLI-33 - Gaming Laboratories International Event Wagering Systems
2 source controls mapped|1 target controls covered
6%
GLBA
2 source controls mapped|1 target controls covered
6%
GAMP 5 - Good Automated Manufacturing Practice
2 source controls mapped|2 target controls covered
6%
FTC GLBA Safeguards Rule (16 CFR Part 314)
2 source controls mapped|1 target controls covered
6%
French Sapin II Law (Law No. 2016-1691)
2 source controls mapped|1 target controls covered
6%
Florida Digital Bill of Rights (FDBR)
2 source controls mapped|1 target controls covered
6%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
2 source controls mapped|2 target controls covered
6%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
2 source controls mapped|2 target controls covered
6%
FATF Recommendation 16 - Virtual Asset Travel Rule
2 source controls mapped|1 target controls covered
6%
ISO/IEC 29147:2018
2 source controls mapped|3 target controls covered
6%
ISO/IEC 29134:2023
2 source controls mapped|3 target controls covered
6%
ISO/IEC 27014:2020
2 source controls mapped|3 target controls covered
6%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
2 source controls mapped|4 target controls covered
6%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
2 source controls mapped|3 target controls covered
6%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
2 source controls mapped|1 target controls covered
6%
ISO/IEC 27031:2011
2 source controls mapped|1 target controls covered
6%
ISO/IEC 27007:2020
2 source controls mapped|1 target controls covered
6%
ISO/IEC 29100:2024
2 source controls mapped|3 target controls covered
6%
ISO/IEC 27004:2016
2 source controls mapped|3 target controls covered
6%
ISO/IEC 27050 - Electronic Discovery (Parts 1-4)
2 source controls mapped|1 target controls covered
6%
ASIS SPC.1-2009 - Organizational Resilience Standard
2 source controls mapped|1 target controls covered
6%
ISO/IEC 30111:2019
2 source controls mapped|3 target controls covered
6%
ISO/IEC 38500:2024 - Governance of IT
2 source controls mapped|3 target controls covered
6%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
2 source controls mapped|3 target controls covered
6%
ISO 27018
2 source controls mapped|1 target controls covered
6%
ISO 27017
2 source controls mapped|1 target controls covered
6%
FedRAMP High
2 source controls mapped|1 target controls covered
6%
NIST SP 800-53 Revision 5.1 HIGH
2 source controls mapped|1 target controls covered
6%
FedRAMP Moderate
2 source controls mapped|1 target controls covered
6%
NIST SP 800-53 Rev 5 MODERATE
2 source controls mapped|1 target controls covered
6%
NIST SP 800-53 Rev 5 LOW
2 source controls mapped|1 target controls covered
6%
NIST AI Risk Management Framework (AI RMF 1.0)
2 source controls mapped|2 target controls covered
6%
ISO 37000:2021 - Governance of Organizations
2 source controls mapped|3 target controls covered
6%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
2 source controls mapped|2 target controls covered
6%
ISO 8000 - Data Quality
2 source controls mapped|2 target controls covered
6%
ISO 20400:2017 - Sustainable Procurement
2 source controls mapped|2 target controls covered
6%
PCI PIN Security
2 source controls mapped|1 target controls covered
6%
IEC 60601-1 - Medical Electrical Equipment Safety
2 source controls mapped|2 target controls covered
6%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
2 source controls mapped|3 target controls covered
6%
ISO/SAE 21434
2 source controls mapped|1 target controls covered
6%
Azerbaijan Law on Personal Data (2010)
2 source controls mapped|1 target controls covered
6%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
2 source controls mapped|1 target controls covered
6%
Illinois Biometric Information Privacy Act (BIPA)
2 source controls mapped|3 target controls covered
6%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
2 source controls mapped|2 target controls covered
6%
ISO 22320:2018
2 source controls mapped|3 target controls covered
6%
Annex 11 to EU GMP - Computerised Systems
2 source controls mapped|3 target controls covered
6%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
2 source controls mapped|3 target controls covered
6%
ISO 19011
2 source controls mapped|2 target controls covered
6%
PCI P2PE
2 source controls mapped|1 target controls covered
6%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
2 source controls mapped|3 target controls covered
6%
ISO 56002
2 source controls mapped|4 target controls covered
6%
AICPA Privacy Management Framework (PMF)
2 source controls mapped|2 target controls covered
6%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
2 source controls mapped|1 target controls covered
6%
IAIS Insurance Core Principles (ICPs)
2 source controls mapped|1 target controls covered
6%
ISO 41001:2018 - Facility Management Systems
2 source controls mapped|3 target controls covered
6%
ISO 39001:2012 - Road Traffic Safety Management
2 source controls mapped|3 target controls covered
6%
ISO 37002:2021 - Whistleblowing Management Systems
2 source controls mapped|3 target controls covered
6%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
2 source controls mapped|3 target controls covered
6%
IEC 62351 - Power Systems Communication Security
2 source controls mapped|1 target controls covered
6%
AWS Well-Architected Security Pillar
2 source controls mapped|1 target controls covered
6%
ISO 26262:2018 - Functional Safety for Road Vehicles
2 source controls mapped|1 target controls covered
6%
SANS Incident Handler's Handbook and PICERL Methodology
2 source controls mapped|2 target controls covered
6%
Barbados Data Protection Act 2019
2 source controls mapped|1 target controls covered
6%
Automotive SPICE (ASPICE) v4.0 - Process Assessment Model
2 source controls mapped|2 target controls covered
6%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
2 source controls mapped|1 target controls covered
6%
Azure Security Benchmark
2 source controls mapped|1 target controls covered
6%
APRA CPS 234
2 source controls mapped|1 target controls covered
6%
NIST SP 800-190
2 source controls mapped|1 target controls covered
6%
ISO 27043
2 source controls mapped|1 target controls covered
6%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
2 source controls mapped|1 target controls covered
6%
PCI SSF
2 source controls mapped|1 target controls covered
6%
FFIEC IT Examination Handbook
2 source controls mapped|1 target controls covered
6%
COBIT 2019
2 source controls mapped|1 target controls covered
6%
TISAX - Trusted Information Security Assessment Exchange
1 source controls mapped|1 target controls covered
3%
NIST Privacy Framework
1 source controls mapped|1 target controls covered
3%
NIS2 Directive Implementing Acts
1 source controls mapped|1 target controls covered
3%
NAIC Insurance Data Security Model Law (MDL-668)
1 source controls mapped|1 target controls covered
3%
IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems
1 source controls mapped|1 target controls covered
3%
ISO/IEC 27010:2015
1 source controls mapped|1 target controls covered
3%
NIST SP 800-53 Rev 5
1 source controls mapped|3 target controls covered
3%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
1 source controls mapped|1 target controls covered
3%
FBI CJIS Security Policy
1 source controls mapped|1 target controls covered
3%
SWIFT CSCF
1 source controls mapped|1 target controls covered
3%
GS1 Global Standards - Supply Chain Traceability and Data Security
1 source controls mapped|2 target controls covered
3%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
1 source controls mapped|2 target controls covered
3%
FSSC 22000 - Food Safety System Certification
1 source controls mapped|1 target controls covered
3%
ISO 27005
1 source controls mapped|1 target controls covered
3%
ISO 13485
1 source controls mapped|1 target controls covered
3%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
1 source controls mapped|1 target controls covered
3%
ISO 10005:2005
1 source controls mapped|1 target controls covered
3%
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 182 other compliance frameworks. The top mapping partners are 21 CFR Part 211 - Current Good Manufacturing Practice (74% coverage), NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements (13% coverage), ISO/IEC 27011:2024 (10% 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?
Start your 21 CFR Part 58 - Good Laboratory Practice (GLP) compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about 21 CFR Part 58 - Good Laboratory Practice (GLP) requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 52 controls and track your progress.
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