ISO 13485vsPIC/S Guide to Good Manufacturing Practice for Medicinal Products
See exactly how ISO 13485 controls map to PIC/S Guide to Good Manufacturing Practice for Medicinal Products. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485 maps to PIC/S Guide to Good Manufacturing Practice for Medicinal Products with 16% coverage across 7 directly mapped controls. Analysis of 44 ISO 13485 controls identifies 37 compliance gaps — primarily concentrated in Product Realisation.
Source: TheArtOfService Knowledge Graph | 44 controls analysed | 700 frameworks | 323K+ cross-framework mappings
Control Mappings
Showing 13 of 13 mapped controls across 6 domains. Sign up to explore all 323K+ mappings across 700 frameworks.
QMS(4 mappings)
Resource Management(3 mappings)
Product Realisation(2 mappings)
Measurement(1 mappings)
Improvement(2 mappings)
ISO 13485: Patient Data Protection(1 mappings)
Related Comparisons
Other ISO 13485 comparisons
Other PIC/S Guide to Good Manufacturing Practice for Medicinal Products comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 700 frameworks — at a fraction of consulting costs.
Free
- ✓ 700 framework browser
- ✓ Cross-framework mappings (323K+)
- ✓ 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 ISO 13485 and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
ISO 13485 has 44 controls across its framework, while PIC/S Guide to Good Manufacturing Practice for Medicinal Products covers 9 controls. Direct mapping analysis identifies 7 overlapping controls (16% coverage). The frameworks diverge most significantly in Product Realisation, where 6 ISO 13485 controls have no direct PIC/S Guide to Good Manufacturing Practice for Medicinal Products equivalent.
How many controls map between ISO 13485 and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
Of 44 total ISO 13485 controls, 7 map directly to PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls — representing 16% coverage. The remaining 37 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 13485 to PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
37 ISO 13485 controls have no direct equivalent in PIC/S Guide to Good Manufacturing Practice for Medicinal Products. The highest concentration of gaps is in Product Realisation with 6 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 ISO 13485 and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?
The domain with the highest gap count is Product Realisation (6 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.