GAMP 5 — Good Automated Manufacturing Practice
GAMP 5 (Good Automated Manufacturing Practice Guide, 2nd Edition 2022) is an ISPE guidance document providing a risk-based approach to the validation of computerized systems in the pharmaceutical and healthcare industries. It aligns with regulatory expectations from FDA, EMA, and other agencies. Covers the complete system lifecycle from concept through retirement with emphasis on critical thinking and leveraging supplier activities.
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Framework Domains (5)
Lifecycle Approach (V-Model)
| Code | Title |
|---|---|
| GAMP5-3.1 | User Requirements Specification |
| GAMP5-3.2 | Functional Specification |
| GAMP5-3.3 | Design Specification |
| GAMP5-3.4 | Qualification Protocols (IQ/OQ/PQ) |
Modern Technologies
| Code | Title |
|---|---|
| GAMP5-5.1 | Cloud Computing Validation |
| GAMP5-5.2 | AI/ML Systems |
| GAMP5-5.3 | Agile Development |
Operational Phase
| Code | Title |
|---|---|
| GAMP5-4.1 | Change and Configuration Management |
| GAMP5-4.2 | Periodic Review |
| GAMP5-4.3 | Data Integrity |
Risk Management
Establishing and maintaining a cyber security risk management program
| Code | Title |
|---|---|
| AASB-S2-25a | Risk Identification and Assessment Processes |
| AASB-S2-25b | Opportunity Identification Processes |
| AASB-S2-25c | Integration with Overall Risk Management |
| AESCSF-RM-1 | Cyber Security Risk Management Strategy |
| AESCSF-RM-2 | Risk Assessment Process |
| AESCSF-RM-3 | Risk Response and Mitigation |
| AESCSF-RM-4 | Risk Management Integration |
| CDP-RM-1 | Risk Identification Process |
| CDP-RM-2 | Dependencies and Impacts Assessment |
| CDP-RM-3 | Value Chain Risk Assessment |
| FAA-CS-3.1 | Data-Driven Risk Management |
| FAA-CS-3.2 | Supply Chain Risk Management |
| FAA-CS-3.3 | Vulnerability Assessment |
| GAMP5-1.1 | Risk-Based Approach |
| GAMP5-1.2 | Patient Safety Risk Assessment |
| GAMP5-1.3 | Functional Risk Assessment |
Software Categories
| Code | Title |
|---|---|
| GAMP5-2.1 | Category 1: Infrastructure Software |
| GAMP5-2.3 | Category 3: Non-Configured Software |
| GAMP5-2.4 | Category 4: Configured Software |
| GAMP5-2.5 | Category 5: Custom Software |
| GAMP5-CAT-1 | Category 1 - Infrastructure Software |
| GAMP5-CAT-3 | Category 3 - Non-Configured Products |
| GAMP5-CAT-4 | Category 4 - Configured Products |
| GAMP5-CAT-5 | Category 5 - Custom Applications |
Maps to 613 other frameworks
Frequently Asked Questions
What is GAMP 5 — Good Automated Manufacturing Practice?
GAMP 5 — Good Automated Manufacturing Practice is a compliance framework from International with 5 domains and 34 controls. GAMP 5 (Good Automated Manufacturing Practice Guide, 2nd Edition 2022) is an ISPE guidance document providing a risk-based approach to the validation of computerized systems in the pharmaceutical and healthcare industries. It aligns with regulatory expectations from FDA, EMA, and other agencies. Covers the complete system lifecycle from concept through retirement with emphasis on critical thinking and leveraging supplier activities. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does GAMP 5 — Good Automated Manufacturing Practice have?
GAMP 5 — Good Automated Manufacturing Practice has 34 controls organised across 5 domains. The largest domains are Risk Management (16 controls), Software Categories (8 controls), Lifecycle Approach (V-Model) (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does GAMP 5 — Good Automated Manufacturing Practice map to?
GAMP 5 — Good Automated Manufacturing Practice maps to 613 other compliance frameworks. The top mapping partners are NIST SP 800-82 Rev 3 — Guide to OT Security (32% coverage), PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments (29% coverage), Canada ITSG-33 — IT Security Risk Management (29% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with GAMP 5 — Good Automated Manufacturing Practice compliance?
Start your GAMP 5 — Good Automated Manufacturing Practice compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about GAMP 5 — Good Automated Manufacturing Practice requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 34 controls and track your progress.
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