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.
Need this as a report you can hand to an assessor? A coverage crosswalk for this pair can be built to order.
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 84% coverage across 23 directly mapped controls. Analysis of 25 21 CFR Part 58 - Good Laboratory Practice (GLP) controls identifies 9 compliance gaps, primarily concentrated in Disqualification of Testing Facilities (Subpart K).
Source: TheArtOfService Knowledge Graph | 25 controls analysed | 686 frameworks | 310K+ cross-framework mappings
Control Mappings
Showing 20 of 30 mapped controls across 6 domains. Sign up to explore all 310K+ mappings across 686 frameworks.
General Provisions (Subpart A)(3 mappings)
Test Articles and Protocol (Subparts F & G)(6 mappings)
Records and Reports (Subpart J)(3 mappings)
Organization and Personnel (Subpart B)(5 mappings)
Facilities (Subpart C)(3 mappings)
+10 more mappings
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A 21 CFR Part 58 - Good Laboratory Practice (GLP) to 21 CFR Part 211 - Current Good Manufacturing Practice crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which 21 CFR Part 211 - Current Good Manufacturing Practice controls your existing 21 CFR Part 58 - Good Laboratory Practice (GLP) work already satisfies, which are real gaps, and the reasoning behind every claim so you can check it. One pair, $299, one time.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
- Every evidenced control, with the reasoning behind it
- Every gap, with what it requires
- Its level of review stated plainly, not a bare number
Why this page shows two different percentages. The 84% in the header counts how many 21 CFR Part 58 - Good Laboratory Practice (GLP) controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many 21 CFR Part 211 - Current Good Manufacturing Practice controls are actually evidenced, after a pass that argued against each mapping and kept only what survived. They answer different questions and they are not meant to agree.
A crosswalk narrows the work. It does not replace an audit, and your assessor may take a different view on individual controls. Mappings between frameworks are judgements, not text printed in either standard, which is why every claim in the report shows its reasoning. Questions go to support@theartofservice.com.
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 25 controls across its framework, while 21 CFR Part 211 - Current Good Manufacturing Practice covers 76 controls. Direct mapping analysis identifies 23 overlapping controls (84% coverage). The frameworks diverge most significantly in Disqualification of Testing Facilities (Subpart K), where 5 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 25 total 21 CFR Part 58 - Good Laboratory Practice (GLP) controls, 23 map directly to 21 CFR Part 211 - Current Good Manufacturing Practice controls, representing 84% coverage. The remaining 9 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?
9 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 5 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) (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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.