PIC/S Guide to Good Manufacturing Practice for Medicinal ProductsvsEU Medical Devices Regulation (MDR 2017/745)
See exactly how PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls map to EU Medical Devices Regulation (MDR 2017/745). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
PIC/S Guide to Good Manufacturing Practice for Medicinal Products maps to EU Medical Devices Regulation (MDR 2017/745) with 35% coverage across 6 directly mapped controls. Analysis of 17 PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls identifies 11 compliance gaps — primarily concentrated in Chapters 7-9 - Outsourcing, Complaints, Self-Inspection.
Source: TheArtOfService Knowledge Graph | 17 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 15 of 15 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Chapter 1 - Pharmaceutical Quality System(9 mappings)
Chapter 3 - Premises and Equipment(4 mappings)
Chapter 4 - Documentation(2 mappings)
Related Comparisons
Other PIC/S Guide to Good Manufacturing Practice for Medicinal Products comparisons
Other EU Medical Devices Regulation (MDR 2017/745) comparisons
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What are the key differences between PIC/S Guide to Good Manufacturing Practice for Medicinal Products and EU Medical Devices Regulation (MDR 2017/745)?
PIC/S Guide to Good Manufacturing Practice for Medicinal Products has 17 controls across its framework, while EU Medical Devices Regulation (MDR 2017/745) covers 20 controls. Direct mapping analysis identifies 6 overlapping controls (35% coverage). The frameworks diverge most significantly in Chapters 7-9 - Outsourcing, Complaints, Self-Inspection, where 3 PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls have no direct EU Medical Devices Regulation (MDR 2017/745) equivalent.
How many controls map between PIC/S Guide to Good Manufacturing Practice for Medicinal Products and EU Medical Devices Regulation (MDR 2017/745)?
Of 17 total PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls, 6 map directly to EU Medical Devices Regulation (MDR 2017/745) controls — representing 35% coverage. The remaining 11 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping PIC/S Guide to Good Manufacturing Practice for Medicinal Products to EU Medical Devices Regulation (MDR 2017/745)?
11 PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls have no direct equivalent in EU Medical Devices Regulation (MDR 2017/745). The highest concentration of gaps is in Chapters 7-9 - Outsourcing, Complaints, Self-Inspection with 3 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 PIC/S Guide to Good Manufacturing Practice for Medicinal Products and EU Medical Devices Regulation (MDR 2017/745)?
The domain with the highest gap count is Chapters 7-9 - Outsourcing, Complaints, Self-Inspection (3 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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