Cross-Framework Mapping

PIC/S Guide to Good Manufacturing Practice for Medicinal Productsvs21 CFR Part 211 - Current Good Manufacturing Practice

See exactly how PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls map to 21 CFR Part 211 - Current Good Manufacturing Practice. Pre-computed mappings, identified gaps, and coverage analysis.

10
Controls Mapped
0
Gaps Found
56%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

PIC/S Guide to Good Manufacturing Practice for Medicinal Products maps to 21 CFR Part 211 - Current Good Manufacturing Practice with 56% coverage across 5 directly mapped controls. Analysis of 9 PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls identifies 4 compliance gaps — primarily concentrated in Self Inspection.

Source: TheArtOfService Knowledge Graph | 9 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 10 of 10 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Personnel(1 mappings)

PICSGMP-2Chapter 2: Personnel - Qualified Personnel, Key Responsibilities, Training
CFR211-A-3Section 211.3 - Definitions

Premises and Equipment(3 mappings)

PICSGMP-3Chapter 3: Premises and Equipment - Design, Qualification, Calibration3 targets
CFR211-C-48Section 211.48 - Plumbing
CFR211-F-113Section 211.113 - Control of Microbiological Contamination
CFR211-I-176Section 211.176 - Penicillin Contamination

Documentation(3 mappings)

PICSGMP-4Chapter 4: Documentation - System, Record-Keeping, Data Integrity3 targets
CFR211-C-48Section 211.48 - Plumbing
CFR211-F-113Section 211.113 - Control of Microbiological Contamination
CFR211-I-176Section 211.176 - Penicillin Contamination

Production(1 mappings)

PICSGMP-5Chapter 5: Production Operations and Material Management
CFR211-A-3Section 211.3 - Definitions

Outsourced Activities(2 mappings)

PICSGMP-7Chapter 7: Outsourced Activities and Supplier Management2 targets
CFR211-A-3Section 211.3 - Definitions
CFR211-J-184Section 211.184 - Component, Drug Product Container, Closure, and Labeling Records

Related Comparisons

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

Other 21 CFR Part 211 - Current Good Manufacturing Practice comparisons

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What are the key differences between PIC/S Guide to Good Manufacturing Practice for Medicinal Products and 21 CFR Part 211 - Current Good Manufacturing Practice?

PIC/S Guide to Good Manufacturing Practice for Medicinal Products has 9 controls across its framework, while 21 CFR Part 211 - Current Good Manufacturing Practice covers 78 controls. Direct mapping analysis identifies 5 overlapping controls (56% coverage). The frameworks diverge most significantly in Self Inspection, where 1 PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls have no direct 21 CFR Part 211 - Current Good Manufacturing Practice equivalent.

How many controls map between PIC/S Guide to Good Manufacturing Practice for Medicinal Products and 21 CFR Part 211 - Current Good Manufacturing Practice?

Of 9 total PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls, 5 map directly to 21 CFR Part 211 - Current Good Manufacturing Practice controls — representing 56% coverage. The remaining 4 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 21 CFR Part 211 - Current Good Manufacturing Practice?

4 PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls have no direct equivalent in 21 CFR Part 211 - Current Good Manufacturing Practice. The highest concentration of gaps is in Self Inspection with 1 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 21 CFR Part 211 - Current Good Manufacturing Practice?

The domain with the highest gap count is Self Inspection (1 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.