Cross-Framework Mapping

API 1164vsGAMP 5 — Good Automated Manufacturing Practice

See exactly how API 1164 controls map to GAMP 5 — Good Automated Manufacturing Practice. Pre-computed mappings, identified gaps, and coverage analysis.

17
Controls Mapped
7
Gaps Found
29%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

API 1164 maps to GAMP 5 — Good Automated Manufacturing Practice with 29% coverage across 7 directly mapped controls. Analysis of 24 API 1164 controls identifies 17 compliance gaps — primarily concentrated in API 1164: Incident Response & Recovery.

Source: TheArtOfService Knowledge Graph | 24 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 17 of 17 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

API 1164: Asset Identification & Governance(1 mappings)

API1164-05Security policy for operational technology
AESCSF-RM-2Risk Assessment Process

API 1164: Access Management(3 mappings)

API1164-07Personnel risk assessment3 targets
CDP-RM-1Risk Identification Process
CDP-RM-3Value Chain Risk Assessment
GAMP5-1.2Patient Safety Risk Assessment

API 1164: Systems Security(1 mappings)

API1164-14System security hardening
GAMP5-4.1Change and Configuration Management

API 1164: Supply Chain & Configuration(12 mappings)

API1164-21Supply chain risk management for critical components4 targets
FAA-CS-3.1Data-Driven Risk Management
FAA-CS-3.2Supply Chain Risk Management
GAMP5-1.1Risk-Based Approach
GAMP5-5.1Cloud Computing Validation
API1164-22Configuration management for OT systems3 targets
FAA-CS-3.2Supply Chain Risk Management
GAMP5-4.1Change and Configuration Management
GAMP5-5.1Cloud Computing Validation
API1164-23Change management procedures2 targets
FAA-CS-3.2Supply Chain Risk Management
GAMP5-5.1Cloud Computing Validation
API1164-24Vulnerability assessment for critical systems3 targets
CDP-RM-1Risk Identification Process
CDP-RM-3Value Chain Risk Assessment
GAMP5-1.2Patient Safety Risk Assessment

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What are the key differences between API 1164 and GAMP 5 — Good Automated Manufacturing Practice?

API 1164 has 24 controls across its framework, while GAMP 5 — Good Automated Manufacturing Practice covers 34 controls. Direct mapping analysis identifies 7 overlapping controls (29% coverage). The frameworks diverge most significantly in API 1164: Incident Response & Recovery, where 5 API 1164 controls have no direct GAMP 5 — Good Automated Manufacturing Practice equivalent.

How many controls map between API 1164 and GAMP 5 — Good Automated Manufacturing Practice?

Of 24 total API 1164 controls, 7 map directly to GAMP 5 — Good Automated Manufacturing Practice controls — representing 29% coverage. The remaining 17 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping API 1164 to GAMP 5 — Good Automated Manufacturing Practice?

17 API 1164 controls have no direct equivalent in GAMP 5 — Good Automated Manufacturing Practice. The highest concentration of gaps is in API 1164: Incident Response & Recovery with 5 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 API 1164 and GAMP 5 — Good Automated Manufacturing Practice?

The domain with the highest gap count is API 1164: Incident Response & Recovery (5 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.