21 CFR Part 211 — Current Good Manufacturing PracticevsICH E6(R3) — Good Clinical Practice
See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to ICH E6(R3) — Good Clinical Practice. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
21 CFR Part 211 — Current Good Manufacturing Practice maps to ICH E6(R3) — Good Clinical Practice with 5% coverage across 3 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 54 compliance gaps — primarily concentrated in Subpart J — Records and Reports.
Source: TheArtOfService Knowledge Graph | 57 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Subpart C — Buildings and Facilities(1 mappings)
Subpart F — Production and Process Controls(1 mappings)
Subpart I — Laboratory Controls(1 mappings)
Related Comparisons
Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons
Other ICH E6(R3) — Good Clinical Practice comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 693 frameworks — at a fraction of consulting costs.
Free
- ✓ 693 framework browser
- ✓ Cross-framework mappings (819K+)
- ✓ 824 compliance assessments
- ✓ 3 AI queries & searches per day
Professional
- ✓ Unlimited AI Compliance Advisory
- ✓ Unlimited full-text search
- ✓ Framework self-assessment
- ✓ PDF, Excel & CSV exports
What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and ICH E6(R3) — Good Clinical Practice?
21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while ICH E6(R3) — Good Clinical Practice covers 17 controls. Direct mapping analysis identifies 3 overlapping controls (5% 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 ICH E6(R3) — Good Clinical Practice equivalent.
How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and ICH E6(R3) — Good Clinical Practice?
Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 3 map directly to ICH E6(R3) — Good Clinical Practice controls — representing 5% coverage. The remaining 54 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 ICH E6(R3) — Good Clinical Practice?
54 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in ICH E6(R3) — Good Clinical Practice. 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 ICH E6(R3) — Good Clinical Practice?
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.
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.