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 (15)
Compliance
| Code | Title |
|---|---|
| GAMP5-12 | Electronic Signatures 21 CFR Part 11 |
Data Integrity
| Code | Title |
|---|---|
| GAMP5-10 | Audit Trail Review |
| GAMP5-9 | Data Integrity Controls ALCOA+ |
Lifecycle
| Code | Title |
|---|---|
| GAMP5-19 | Decommissioning and Retirement |
| GAMP5-2 | System Categorisation |
| GAMP5-6 | Traceability Matrix |
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 |
Operations
| Code | Title |
|---|---|
| GAMP5-13 | Change Control |
| GAMP5-14 | Periodic Review |
| GAMP5-15 | Backup, Restore and Archive |
| GAMP5-16 | Business Continuity for GxP Systems |
| GAMP5-17 | Incident and Problem Management |
People
| Code | Title |
|---|---|
| GAMP5-18 | Training and Competency |
Risk Management
| 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 | Quality Risk Management Approach |
| GAMP5-1.1 | Risk-Based Approach |
| GAMP5-1.2 | Patient Safety Risk Assessment |
| GAMP5-1.3 | Functional Risk Assessment |
| GAMP5-20 | Critical Thinking and Effort Justification |
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 | Quality Risk Management Approach |
| GAMP5-1.1 | Risk-Based Approach |
| GAMP5-1.2 | Patient Safety Risk Assessment |
| GAMP5-1.3 | Functional Risk Assessment |
| GAMP5-20 | Critical Thinking and Effort Justification |
Security
| Code | Title |
|---|---|
| GAMP5-11 | Access Control and Segregation of Duties |
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 |
Specification
| Code | Title |
|---|---|
| GAMP5-4 | User Requirements Specification |
| GAMP5-5 | Functional and Configuration Specifications |
Testing
| Code | Title |
|---|---|
| GAMP5-7 | Installation and Operational Qualification |
| GAMP5-8 | Performance Qualification |
Vendor Management
| Code | Title |
|---|---|
| GAMP5-3 | Supplier Assessment |
Your Compliance Coverage
If you comply with GAMP 5 — Good Automated Manufacturing Practice, you already cover:
C2M2
20%
11 controls mapped
Compare →NIST SP 800-82 Rev 3 — Guide to OT Security
20%
11 controls mapped
Compare →NIS2 Directive
20%
11 controls mapped
Compare →+ 632 more: PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments (19%), Canada ITSG-33 — IT Security Risk Management (19%)
See all 635 mapped frameworks ↓Maps to 635 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 15 domains and 54 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 54 controls organised across 15 domains. The largest domains are Risk Management (16 controls), Software Categories (8 controls), Operations (5 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 635 other compliance frameworks. The top mapping partners are C2M2 (20% coverage), NIST SP 800-82 Rev 3 — Guide to OT Security (20% coverage), NIS2 Directive (20% 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?
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