Cross-Framework Mapping

21 CFR Part 211 - Current Good Manufacturing Practicevs21 CFR Part 58 - Good Laboratory Practice (GLP)

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

54
Controls Mapped
24
Gaps Found
21%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

21 CFR Part 211 - Current Good Manufacturing Practice maps to 21 CFR Part 58 - Good Laboratory Practice (GLP) with 21% coverage across 16 directly mapped controls. Analysis of 78 21 CFR Part 211 - Current Good Manufacturing Practice controls identifies 62 compliance gaps — primarily concentrated in Subpart J - Records and Reports.

Source: TheArtOfService Knowledge Graph | 78 controls analysed | 723 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 54 mapped controls across 12 domains. Sign up to explore all 332K+ mappings across 723 frameworks.

Production and Process Controls(6 mappings)

211.100Written Procedures for Production and Process Control6 targets
58.120Protocol
58.120Protocol
58.130Conduct of a Nonclinical Laboratory Study
58.130Conduct of a Nonclinical Laboratory Study
58.81Standard Operating Procedures
58.81Standard Operating Procedures

Packaging and Labeling Control(6 mappings)

211.122Materials Examination and Usage Criteria6 targets
58.105Test and Control Article Characterization
58.105Test and Control Article Characterization
58.107Test and Control Article Handling
58.107Test and Control Article Handling
58.83Reagents and Solutions
58.83Reagents and Solutions

Holding and Distribution(2 mappings)

211.142Warehousing Procedures2 targets
58.107Test and Control Article Handling
58.107Test and Control Article Handling

Records and Reports(6 mappings)

211.180General Records Requirements6 targets
58.190Storage and Retrieval of Records and Data
58.190Storage and Retrieval of Records and Data
58.195Retention of Records
58.195Retention of Records
58.51Specimen and Data Storage Facilities
58.51Specimen and Data Storage Facilities

+34 more mappings

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Related Comparisons

Other 21 CFR Part 211 - Current Good Manufacturing Practice comparisons

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

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

21 CFR Part 211 - Current Good Manufacturing Practice has 78 controls across its framework, while 21 CFR Part 58 - Good Laboratory Practice (GLP) covers 31 controls. Direct mapping analysis identifies 16 overlapping controls (21% coverage). The frameworks diverge most significantly in Subpart J - Records and Reports, where 9 21 CFR Part 211 - Current Good Manufacturing Practice controls have no direct 21 CFR Part 58 - Good Laboratory Practice (GLP) equivalent.

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

Of 78 total 21 CFR Part 211 - Current Good Manufacturing Practice controls, 16 map directly to 21 CFR Part 58 - Good Laboratory Practice (GLP) controls — representing 21% coverage. The remaining 62 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 211 - Current Good Manufacturing Practice to 21 CFR Part 58 - Good Laboratory Practice (GLP)?

62 21 CFR Part 211 - Current Good Manufacturing Practice controls have no direct equivalent in 21 CFR Part 58 - Good Laboratory Practice (GLP). The highest concentration of gaps is in Subpart J - Records and Reports with 9 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 211 - Current Good Manufacturing Practice and 21 CFR Part 58 - Good Laboratory Practice (GLP)?

The domain with the highest gap count is Subpart J - Records and Reports (9 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.