Cross-Framework Mapping

ISO/IEC 17025:2017 - General Requirements for Testing and Calibration LaboratoriesvsPIC/S Guide to Good Manufacturing Practice for Medicinal Products

See exactly how ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories controls map to PIC/S Guide to Good Manufacturing Practice for Medicinal Products. Pre-computed mappings, identified gaps, and coverage analysis.

21
Controls Mapped
69
Gaps Found
13%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories maps to PIC/S Guide to Good Manufacturing Practice for Medicinal Products with 13% coverage across 12 directly mapped controls. Analysis of 90 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories controls identifies 78 compliance gaps — primarily concentrated in Clause 7: Process Requirements.

Source: TheArtOfService Knowledge Graph | 90 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 21 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Clause 6: Resource Requirements(10 mappings)

ISO-15189-6.3Facilities and environmental conditions2 targets
PICSGMP-3Chapter 3: Premises and Equipment - Design, Qualification, Calibration
PICSGMP-4Chapter 4: Documentation - System, Record-Keeping, Data Integrity
ISO-15189-6.5Equipment calibration and metrological traceability2 targets
PICSGMP-3Chapter 3: Premises and Equipment - Design, Qualification, Calibration
PICSGMP-4Chapter 4: Documentation - System, Record-Keeping, Data Integrity
ISO-15189-6.7Service agreements3 targets
PICSGMP-2Chapter 2: Personnel - Qualified Personnel, Key Responsibilities, Training
PICSGMP-5Chapter 5: Production Operations and Material Management
PICSGMP-7Chapter 7: Outsourced Activities and Supplier Management
ISO-15189-6.8Externally provided products and services
PICSGMP-7Chapter 7: Outsourced Activities and Supplier Management
ISO-17025-6.5Metrological traceability2 targets
PICSGMP-3Chapter 3: Premises and Equipment - Design, Qualification, Calibration
PICSGMP-4Chapter 4: Documentation - System, Record-Keeping, Data Integrity

Clause 7: Process Requirements(1 mappings)

ISO-15189-7.4Post-examination processes
PICSGMP-1Chapter 1: Pharmaceutical Quality System (PQS) and Quality Risk Management

Clause 8: Management System Requirements(4 mappings)

ISO-15189-8.1General requirements
PICSGMP-1Chapter 1: Pharmaceutical Quality System (PQS) and Quality Risk Management
ISO-15189-8.4Control of records
PICSGMP-1Chapter 1: Pharmaceutical Quality System (PQS) and Quality Risk Management
ISO-17025-8.1Options
PICSGMP-1Chapter 1: Pharmaceutical Quality System (PQS) and Quality Risk Management
ISO-17025-8.7Corrective actions
PICSGMP-1Chapter 1: Pharmaceutical Quality System (PQS) and Quality Risk Management

Clause 5: Structural Requirements(5 mappings)

ISO-17025-5.1Legal entity3 targets
PICSGMP-2Chapter 2: Personnel - Qualified Personnel, Key Responsibilities, Training
PICSGMP-5Chapter 5: Production Operations and Material Management
PICSGMP-7Chapter 7: Outsourced Activities and Supplier Management
ISO-17025-5.4Personnel for the management system2 targets
PICSGMP-2Chapter 2: Personnel - Qualified Personnel, Key Responsibilities, Training
PICSGMP-5Chapter 5: Production Operations and Material Management

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Related Comparisons

Other ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories comparisons

Other PIC/S Guide to Good Manufacturing Practice for Medicinal Products comparisons

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What are the key differences between ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?

ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories has 90 controls across its framework, while PIC/S Guide to Good Manufacturing Practice for Medicinal Products covers 9 controls. Direct mapping analysis identifies 12 overlapping controls (13% coverage). The frameworks diverge most significantly in Clause 7: Process Requirements, where 18 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories controls have no direct PIC/S Guide to Good Manufacturing Practice for Medicinal Products equivalent.

How many controls map between ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?

Of 90 total ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories controls, 12 map directly to PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls — representing 13% coverage. The remaining 78 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories to PIC/S Guide to Good Manufacturing Practice for Medicinal Products?

78 ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories controls have no direct equivalent in PIC/S Guide to Good Manufacturing Practice for Medicinal Products. The highest concentration of gaps is in Clause 7: Process Requirements with 18 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/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?

The domain with the highest gap count is Clause 7: Process Requirements (18 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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