Cross-Framework Mapping

21 CFR Part 58 - Good Laboratory Practice (GLP)vs21 CFR Part 211 - Current Good Manufacturing Practice

See exactly how 21 CFR Part 58 - Good Laboratory Practice (GLP) controls map to 21 CFR Part 211 - Current Good Manufacturing Practice. Pre-computed mappings, identified gaps, and coverage analysis.

54
Controls Mapped
0
Gaps Found
74%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

21 CFR Part 58 - Good Laboratory Practice (GLP) maps to 21 CFR Part 211 - Current Good Manufacturing Practice with 74% coverage across 42 directly mapped controls. Analysis of 31 21 CFR Part 58 - Good Laboratory Practice (GLP) controls identifies 10 compliance gaps — primarily concentrated in Disqualification of Testing Facilities (Subpart K).

Source: TheArtOfService Knowledge Graph | 31 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 54 mapped controls across 13 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

General Provisions (Subpart A)(3 mappings)

58.1Scope
CFR211-A-3Section 211.3 - Definitions
58.15Inspection of Testing Facility
211.22Responsibilities of Quality Control Unit
58.3Definitions
CFR211-A-3Section 211.3 - Definitions

Test and Control Articles(4 mappings)

58.105Test and Control Article Characterization2 targets
211.122Materials Examination and Usage Criteria
211.84Testing and Approval of Components
58.107Test and Control Article Handling2 targets
211.122Materials Examination and Usage Criteria
211.142Warehousing Procedures

Test Articles and Protocol (Subparts F & G)(6 mappings)

58.105Test and Control Article Characterization2 targets
211.122Materials Examination and Usage Criteria
211.84Testing and Approval of Components
58.107Test and Control Article Handling2 targets
211.122Materials Examination and Usage Criteria
211.142Warehousing Procedures
58.120Protocol
211.100Written Procedures for Production and Process Control
58.130Conduct of a Nonclinical Laboratory Study
211.100Written Procedures for Production and Process Control

Protocol and Conduct of Study(2 mappings)

58.120Protocol
211.100Written Procedures for Production and Process Control
58.130Conduct of a Nonclinical Laboratory Study
211.100Written Procedures for Production and Process Control

Records and Reports(3 mappings)

58.185Reporting of Nonclinical Laboratory Study Results
211.192Production Record Review
58.190Storage and Retrieval of Records and Data
211.180General Records Requirements
58.195Retention of Records
211.180General Records Requirements

Records and Reports (Subpart J)(2 mappings)

58.185Reporting of Nonclinical Laboratory Study Results
211.192Production Record Review
58.190Storage and Retrieval of Records and Data
211.180General Records Requirements

+34 more mappings

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Related Comparisons

Other 21 CFR Part 58 - Good Laboratory Practice (GLP) comparisons

Other 21 CFR Part 211 - Current Good Manufacturing Practice comparisons

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What are the key differences between 21 CFR Part 58 - Good Laboratory Practice (GLP) and 21 CFR Part 211 - Current Good Manufacturing Practice?

21 CFR Part 58 - Good Laboratory Practice (GLP) has 31 controls across its framework, while 21 CFR Part 211 - Current Good Manufacturing Practice covers 78 controls. Direct mapping analysis identifies 42 overlapping controls (74% coverage). The frameworks diverge most significantly in Disqualification of Testing Facilities (Subpart K), where 4 21 CFR Part 58 - Good Laboratory Practice (GLP) controls have no direct 21 CFR Part 211 - Current Good Manufacturing Practice equivalent.

How many controls map between 21 CFR Part 58 - Good Laboratory Practice (GLP) and 21 CFR Part 211 - Current Good Manufacturing Practice?

Of 31 total 21 CFR Part 58 - Good Laboratory Practice (GLP) controls, 42 map directly to 21 CFR Part 211 - Current Good Manufacturing Practice controls — representing 74% coverage. The remaining 10 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping 21 CFR Part 58 - Good Laboratory Practice (GLP) to 21 CFR Part 211 - Current Good Manufacturing Practice?

10 21 CFR Part 58 - Good Laboratory Practice (GLP) controls have no direct equivalent in 21 CFR Part 211 - Current Good Manufacturing Practice. The highest concentration of gaps is in Disqualification of Testing Facilities (Subpart K) with 4 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.

Which control domains have the most gaps between 21 CFR Part 58 - Good Laboratory Practice (GLP) and 21 CFR Part 211 - Current Good Manufacturing Practice?

The domain with the highest gap count is Disqualification of Testing Facilities (Subpart K) (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.