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21 CFR Part 58 - Good Laboratory Practice (GLP)

Self-Assess
United States
vCurrent (as amended)
7 domains
32 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

21 CFR Part 58 - Good Laboratory Practice (GLP) is a compliance framework from United States with 7 domains and 32 controls that map to 49 other frameworks. The largest domains are Facilities (Subpart C) (6 controls), Disqualification of Testing Facilities (Subpart K) (5 controls), Equipment and Operations (Subparts D & E) (5 controls). Every control below carries what it requires and what an assessor expects to see.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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 (7)

Disqualification of Testing Facilities (Subpart K)

5 controls
Controls in the Disqualification of Testing Facilities (Subpart K) domain of 21 CFR Part 58 - Good Laboratory Practice (GLP) — 1 controls
CodeTitle
21CFR58-58.217Suspension or Termination of a Testing Facility by a Sponsor

Equipment and Operations (Subparts D & E)

5 controls
Controls in the Equipment and Operations (Subparts D & E) domain of 21 CFR Part 58 - Good Laboratory Practice (GLP) — 5 controls
CodeTitle
58.61Equipment Design
58.63Maintenance and Calibration of Equipment
58.81Standard Operating Procedures
58.83Reagents and Solutions
58.90Animal Care

Facilities (Subpart C)

6 controls
Controls in the Facilities (Subpart C) domain of 21 CFR Part 58 - Good Laboratory Practice (GLP) — 6 controls
CodeTitle
58.41General Facility Requirements
58.43Animal Care Facilities
58.45Animal Supply Facilities
58.47Laboratory Operation Areas
58.49Laboratory Operation Areas
58.51Specimen and Data Storage Facilities

General Provisions (Subpart A)

4 controls
Controls in the General Provisions (Subpart A) domain of 21 CFR Part 58 - Good Laboratory Practice (GLP) — 1 controls
CodeTitle
58.15Inspection of Testing Facility

Organization and Personnel (Subpart B)

4 controls
Controls in the Organization and Personnel (Subpart B) domain of 21 CFR Part 58 - Good Laboratory Practice (GLP) — 4 controls
CodeTitle
58.29Personnel
58.31Testing Facility Management
58.33Study Director
58.35Quality Assurance Unit

Records and Reports (Subpart J)

3 controls
Controls in the Records and Reports (Subpart J) domain of 21 CFR Part 58 - Good Laboratory Practice (GLP) — 3 controls
CodeTitle
58.185Reporting of Nonclinical Laboratory Study Results
58.190Storage and Retrieval of Records and Data
58.195Retention of Records

Test Articles and Protocol (Subparts F & G)

5 controls
Controls in the Test Articles and Protocol (Subparts F & G) domain of 21 CFR Part 58 - Good Laboratory Practice (GLP) — 5 controls
CodeTitle
58.105Test and Control Article Characterization
58.107Test and Control Article Handling
58.113Mixtures of Articles with Carriers
58.120Protocol
58.130Conduct of a Nonclinical Laboratory Study

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

84%

21 controls mapped

Compare →

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements

8%

2 controls mapped

Compare →

ISO/IEC 27011:2024

4%

1 controls mapped

Compare →

+ 46 more: UK Gambling Commission - Cyber Resilience Requirements (4%), TISAX - Trusted Information Security Assessment Exchange (4%)

See all 49 mapped frameworks ↓

Maps to 49 other frameworks

25 total controls
21 CFR Part 211 - Current Good Manufacturing Practice
21 source controls mapped|15 target controls covered
84%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
2 source controls mapped|4 target controls covered
8%
ISO/IEC 27011:2024
1 source controls mapped|2 target controls covered
4%
UK Gambling Commission - Cyber Resilience Requirements
1 source controls mapped|1 target controls covered
4%
TISAX - Trusted Information Security Assessment Exchange
1 source controls mapped|1 target controls covered
4%
Protective Security Policy Framework (PSPF) Release 2024
1 source controls mapped|1 target controls covered
4%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
1 source controls mapped|1 target controls covered
4%
NIST Privacy Framework
1 source controls mapped|1 target controls covered
4%
NIS2 Directive Implementing Acts
1 source controls mapped|1 target controls covered
4%
NAIC Insurance Data Security Model Law (MDL-668)
1 source controls mapped|1 target controls covered
4%
ICAO Annex 17 - Aviation Security (AVSEC)
1 source controls mapped|1 target controls covered
4%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
1 source controls mapped|1 target controls covered
4%
IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems
1 source controls mapped|1 target controls covered
4%
FedRAMP Rev 5
1 source controls mapped|1 target controls covered
4%
ISO/IEC 27010:2015
1 source controls mapped|1 target controls covered
4%
ISO/IEC 27400:2022
1 source controls mapped|1 target controls covered
4%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
1 source controls mapped|1 target controls covered
4%
SOC for Cybersecurity - Cybersecurity Risk Management Examination
1 source controls mapped|1 target controls covered
4%
NIST SP 800-53 Rev 5
1 source controls mapped|3 target controls covered
4%
UK Security and Emergency Measures Direction (SEMD) - Water Industry
1 source controls mapped|2 target controls covered
4%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
1 source controls mapped|1 target controls covered
4%
ISO 28001:2007 Supply Chain Security Management
1 source controls mapped|1 target controls covered
4%
SOC 2
1 source controls mapped|1 target controls covered
4%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
1 source controls mapped|1 target controls covered
4%
SSAE 18 - Attestation Standards (SOC Reporting)
1 source controls mapped|1 target controls covered
4%
NIST Cybersecurity Framework 2.0
1 source controls mapped|1 target controls covered
4%
Security of Critical Infrastructure Act 2018 (SOCI)
1 source controls mapped|1 target controls covered
4%
FBI CJIS Security Policy
1 source controls mapped|1 target controls covered
4%
SWIFT CSCF
1 source controls mapped|1 target controls covered
4%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
1 source controls mapped|2 target controls covered
4%
ICH E6(R3) - Good Clinical Practice
1 source controls mapped|1 target controls covered
4%
GS1 Global Standards - Supply Chain Traceability and Data Security
1 source controls mapped|2 target controls covered
4%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
1 source controls mapped|2 target controls covered
4%
FSSC 22000 - Food Safety System Certification
1 source controls mapped|1 target controls covered
4%
FDA Quality Management System Regulation (QMSR)
1 source controls mapped|2 target controls covered
4%
BRCGS Global Standard for Food Safety Issue 9
1 source controls mapped|3 target controls covered
4%
Singapore AI Governance Framework
1 source controls mapped|1 target controls covered
4%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
1 source controls mapped|1 target controls covered
4%
AS9100D - Aerospace Quality Management System
1 source controls mapped|1 target controls covered
4%
ISO/IEC 27003:2017
1 source controls mapped|1 target controls covered
4%
ISO 27005
1 source controls mapped|1 target controls covered
4%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
1 source controls mapped|3 target controls covered
4%
ISO 13485
1 source controls mapped|1 target controls covered
4%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration
1 source controls mapped|1 target controls covered
4%
IEC 62304:2015 Medical Device Software Lifecycle Processes
1 source controls mapped|1 target controls covered
4%
PCI DSS 4.0
1 source controls mapped|2 target controls covered
4%
SQF Code Edition 9 - Safe Quality Food
1 source controls mapped|1 target controls covered
4%
ISO/IEC 25012:2008 - Data Quality Model
1 source controls mapped|1 target controls covered
4%
ISO 10006:2003
1 source controls mapped|1 target controls covered
4%
Compare 21 CFR Part 58 - Good Laboratory Practice (GLP) with 21 CFR Part 211 - Current Good Manufacturing Practice

What is 21 CFR Part 58 - Good Laboratory Practice (GLP) and who does it apply to?

21 CFR Part 58 - Good Laboratory Practice (GLP) is a compliance framework from United States with 7 domains and 32 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.

What does 21 CFR Part 58 - Good Laboratory Practice (GLP) actually require?

21 CFR Part 58 - Good Laboratory Practice (GLP) has 32 controls organised across 7 domains. The largest domains are Facilities (Subpart C) (6 controls), Disqualification of Testing Facilities (Subpart K) (5 controls), Equipment and Operations (Subparts D & E) (5 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

If I already comply with another framework, how much of 21 CFR Part 58 - Good Laboratory Practice (GLP) do I already cover?

21 CFR Part 58 - Good Laboratory Practice (GLP) maps to 49 other compliance frameworks. The top mapping partners are 21 CFR Part 211 - Current Good Manufacturing Practice (84% coverage), NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements (8% coverage), ISO/IEC 27011:2024 (4% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I implement 21 CFR Part 58 - Good Laboratory Practice (GLP)?

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 32 controls and track your progress.

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