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.
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)
Test and Control Articles(4 mappings)
Test Articles and Protocol (Subparts F & G)(6 mappings)
Protocol and Conduct of Study(2 mappings)
Records and Reports(3 mappings)
Records and Reports (Subpart J)(2 mappings)
+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.
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