Cross-Framework Mapping

ISO 56002vsPIC/S Guide to Good Manufacturing Practice for Medicinal Products

See exactly how ISO 56002 controls map to PIC/S Guide to Good Manufacturing Practice for Medicinal Products. Pre-computed mappings, identified gaps, and coverage analysis.

15
Controls Mapped
149
Gaps Found
4%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 56002 maps to PIC/S Guide to Good Manufacturing Practice for Medicinal Products with 4% coverage across 7 directly mapped controls. Analysis of 164 ISO 56002 controls identifies 157 compliance gaps — primarily concentrated in Clause 7: Support.

Source: TheArtOfService Knowledge Graph | 164 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 15 of 15 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Clause 10: Improvement(3 mappings)

ISO-39001-10.1Nonconformity and corrective action
PICSGMP-1Chapter 1: Pharmaceutical Quality System (PQS) and Quality Risk Management
ISO-41001-10.1Nonconformity and corrective action
PICSGMP-1Chapter 1: Pharmaceutical Quality System (PQS) and Quality Risk Management
ISO-56002-10.2Deviation, nonconformity and corrective action
PICSGMP-1Chapter 1: Pharmaceutical Quality System (PQS) and Quality Risk Management

Clause 4: Context of the Organization(9 mappings)

ISO-41001-4.1Understanding the organization and its context3 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-41001-4.3Determining the scope of the FM management system3 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-56002-4.3Determining the scope of the innovation management system3 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

Clause 8: Operations - Innovation Process(3 mappings)

ISO-56002-8.3.4Develop solutions3 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

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What are the key differences between ISO 56002 and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?

ISO 56002 has 164 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 (4% coverage). The frameworks diverge most significantly in Clause 7: Support, where 34 ISO 56002 controls have no direct PIC/S Guide to Good Manufacturing Practice for Medicinal Products equivalent.

How many controls map between ISO 56002 and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?

Of 164 total ISO 56002 controls, 7 map directly to PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls — representing 4% coverage. The remaining 157 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 56002 to PIC/S Guide to Good Manufacturing Practice for Medicinal Products?

157 ISO 56002 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: Support with 34 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 56002 and PIC/S Guide to Good Manufacturing Practice for Medicinal Products?

The domain with the highest gap count is Clause 7: Support (34 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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.