21 CFR Part 211 — Current Good Manufacturing PracticevsEU General Product Safety Regulation (GPSR, Regulation 2023/988)
See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to EU General Product Safety Regulation (GPSR, Regulation 2023/988). 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 EU General Product Safety Regulation (GPSR, Regulation 2023/988) with 4% coverage across 2 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 55 compliance gaps — primarily concentrated in Subpart F — Production and Process Controls.
Source: TheArtOfService Knowledge Graph | 57 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 6 of 6 mapped controls across 2 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Subpart A — General Provisions(5 mappings)
Subpart J — Records and Reports(1 mappings)
Related Comparisons
Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons
Other EU General Product Safety Regulation (GPSR, Regulation 2023/988) 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 EU General Product Safety Regulation (GPSR, Regulation 2023/988)?
21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while EU General Product Safety Regulation (GPSR, Regulation 2023/988) covers 39 controls. Direct mapping analysis identifies 2 overlapping controls (4% coverage). The frameworks diverge most significantly in Subpart F — Production and Process Controls, where 8 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct EU General Product Safety Regulation (GPSR, Regulation 2023/988) equivalent.
How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and EU General Product Safety Regulation (GPSR, Regulation 2023/988)?
Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 2 map directly to EU General Product Safety Regulation (GPSR, Regulation 2023/988) controls — representing 4% coverage. The remaining 55 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 EU General Product Safety Regulation (GPSR, Regulation 2023/988)?
55 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in EU General Product Safety Regulation (GPSR, Regulation 2023/988). The highest concentration of gaps is in Subpart F — Production and Process Controls with 8 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 EU General Product Safety Regulation (GPSR, Regulation 2023/988)?
The domain with the highest gap count is Subpart F — Production and Process Controls (8 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.