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.

30
Controls Mapped
46
Gaps Found
20%
Coverage

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 211 - Current Good Manufacturing Practice maps to 21 CFR Part 58 - Good Laboratory Practice (GLP) with 20% coverage across 16 directly mapped controls. Analysis of 76 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 | 76 controls analysed | 686 frameworks | 310K+ cross-framework mappings

Control Mappings

Showing 20 of 30 mapped controls across 12 domains. Sign up to explore all 310K+ mappings across 686 frameworks.

Production and Process Controls(3 mappings)

211.100Written Procedures for Production and Process Control3 targets
58.120Protocol
58.130Conduct of a Nonclinical Laboratory Study
58.81Standard Operating Procedures

Packaging and Labeling Control(3 mappings)

211.122Materials Examination and Usage Criteria3 targets
58.105Test and Control Article Characterization
58.107Test and Control Article Handling
58.83Reagents and Solutions

Holding and Distribution(1 mappings)

211.142Warehousing Procedures
58.107Test and Control Article Handling

Records and Reports(4 mappings)

211.180General Records Requirements3 targets
58.190Storage and Retrieval of Records and Data
58.195Retention of Records
58.51Specimen and Data Storage Facilities
211.192Production Record Review
58.185Reporting of Nonclinical Laboratory Study Results

Organization and Personnel(6 mappings)

211.22Responsibilities of Quality Control Unit4 targets
58.15Inspection of Testing Facility
58.31Testing Facility Management
58.33Study Director
58.35Quality Assurance Unit
211.25Personnel Qualifications
58.29Personnel
211.28Personnel Responsibilities and Hygiene
58.29Personnel

Buildings and Facilities(3 mappings)

211.42Design and Construction of Buildings3 targets
58.41General Facility Requirements
58.43Animal Care Facilities
58.47Laboratory Operation Areas

+10 more mappings

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Coverage crosswalk

A 21 CFR Part 211 - Current Good Manufacturing Practice to 21 CFR Part 58 - Good Laboratory Practice (GLP) 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 58 - Good Laboratory Practice (GLP) controls your existing 21 CFR Part 211 - Current Good Manufacturing Practice work already satisfies, which are real gaps, and the reasoning behind every claim so you can check it. One pair, $299, one time.

21 CFR Part 211 - Current Good Manufacturing Practice into 21 CFR Part 58 - Good Laboratory Practice (GLP)
Not published yet

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.

21 CFR Part 58 - Good Laboratory Practice (GLP) into 21 CFR Part 211 - Current Good Manufacturing Practice
Not published yet

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.

21 CFR Part 211 - Current Good Manufacturing Practice to 21 CFR Part 58 - Good Laboratory Practice (GLP) (built to order)
$299
per framework pair, one time
  • 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 20% in the header counts how many 21 CFR Part 211 - Current Good Manufacturing Practice controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many 21 CFR Part 58 - Good Laboratory Practice (GLP) 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 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 76 controls across its framework, while 21 CFR Part 58 - Good Laboratory Practice (GLP) covers 25 controls. Direct mapping analysis identifies 16 overlapping controls (20% 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 76 total 21 CFR Part 211 - Current Good Manufacturing Practice controls, 16 map directly to 21 CFR Part 58 - Good Laboratory Practice (GLP) controls, representing 20% 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.