GAMP 5 - Good Automated Manufacturing Practice
GAMP 5 (Good Automated Manufacturing Practice 5) is the INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING (ISPE) flagship guide for Computerised Systems Validation in GxP-regulated environments (pharmaceutical + medical device + biotech + healthcare manufacturing + laboratories). Current edition GAMP 5 SECOND EDITION published July 2022 + supersedes the 2008 First Edition. KEY CONCEPTS: (a) RISK-BASED APPROACH - effort proportional to risk + complexity + regulatory impact; (b) LIFE CYCLE APPROACH - V-Model lifecycle with Specification + Verification phases mirrored; (c) CRITICAL THINKING - applying judgment over checkbox compliance; (d) LEVERAGE SUPPLIER INVOLVEMENT - reduce duplication via supplier qualification + documentation reuse + audit; (e) SCALABILITY - approach scales from small bench instruments to enterprise ERP/MES; (f) GxP regulatory alignment - 21 CFR Part 11 (FDA Electronic Records + Electronic Signatures) + EU Annex 11 (Computerised Systems) + ICH Q9 Quality Risk Management + ICH Q10 Pharmaceutical Quality System + FDA Computer Software Assurance (CSA) 2023 Draft Guidance. 5 SOFTWARE CATEGORIES (Appendix M4): Category 1 INFRASTRUCTURE (operating systems + databases + network); Category 2 was deprecated in 1st Edition; Category 3 NON-CONFIGURED PRODUCTS (commercial off-the-shelf); Category 4 CONFIGURED PRODUCTS (commercial with configuration); Category 5 CUSTOM APPLICATIONS (in-house developed). 2ND EDITION (2022) UPDATES: AI + machine learning systems; cloud + SaaS; agile + iterative development; DevOps; data integrity by design; explicit critical thinking emphasis; data integrity ALCOA+ deepening; computer software assurance (FDA CSA Draft Guidance 2022) alignment + replacing some traditional CSV. APPLICATION: typical implementation includes URS (User Requirements Specification) + FS (Functional Specification) + DS (Design Specification) + IQ (Installation Qualification) + OQ (Operational Qualification) + PQ (Performance Qualification) + Traceability Matrix + Risk Assessment + Change Control + Periodic Review + Data Integrity Controls + Decommissioning. AUDITORS: FDA + EMA + MHRA + PMDA + Health Canada + Brazilian ANVISA + China NMPA + other regulators inspect against GAMP 5 + Part 11 + Annex 11 + national regulations.
GAMP 5 - Good Automated Manufacturing Practice is a compliance framework from International (pharmaceutical, biotechnology and medical device industry guidance) with 11 domains and 113 controls that map to 91 other frameworks. The largest domains are Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice (20 controls), Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice (20 controls), Chapter 7: Supplier activities (products, applications, services and the supplier good practices) – GAMP 5 - Good Automated Manufacturing Practice (14 controls). Every control below carries what it requires and what an assessor expects to see.
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Framework Domains (11)
Chapter 2: Key concepts (product and process understanding, life cycle within a QMS, scalable activities, science-based QRM, leveraging suppliers) – GAMP 5 - Good Automated Manufacturing Practice
| Code | Title |
|---|---|
| gamp-5-good-automated-manufacturing-practice::2.1.1 | 2.1.1 Product and Process Understanding |
| gamp-5-good-automated-manufacturing-practice::2.1.2 | 2.1.2 Life Cycle Approach within a Quality Management System |
| gamp-5-good-automated-manufacturing-practice::2.1.3 | 2.1.3 Scalable Life Cycle Activities |
| gamp-5-good-automated-manufacturing-practice::2.1.4 | 2.1.4 Science-Based Quality Risk Management |
| gamp-5-good-automated-manufacturing-practice::2.1.5 | 2.1.5 Leveraging Supplier Involvement |
Chapter 3: Life cycle approach (life cycle, specification and verification, validation framework, critical thinking) – GAMP 5 - Good Automated Manufacturing Practice
| Code | Title |
|---|---|
| gamp-5-good-automated-manufacturing-practice::3.1 | 3.1 Computerized System Life Cycle |
| gamp-5-good-automated-manufacturing-practice::3.2 | 3.2 Specification and Verification |
| gamp-5-good-automated-manufacturing-practice::3.3 | 3.3 Computerized System Validation Framework |
| gamp-5-good-automated-manufacturing-practice::3.4 | 3.4 Critical Thinking Through the Life Cycle |
Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice
Chapter 5: Quality risk management (science-based QRM and the five-step process) – GAMP 5 - Good Automated Manufacturing Practice
| Code | Title |
|---|---|
| gamp-5-good-automated-manufacturing-practice::5.2 | 5.2 Science-Based Quality Risk Management |
| gamp-5-good-automated-manufacturing-practice::5.3 | 5.3 Quality Risk Management Process |
Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice
Chapter 7: Supplier activities (products, applications, services and the supplier good practices) – GAMP 5 - Good Automated Manufacturing Practice
| Code | Title |
|---|---|
| gamp-5-good-automated-manufacturing-practice::7.1 | 7.1 Supplier Products, Applications and Services |
| gamp-5-good-automated-manufacturing-practice::7.10 | 7.10 Supplier Testing |
| gamp-5-good-automated-manufacturing-practice::7.11 | 7.11 Commercial Release |
| gamp-5-good-automated-manufacturing-practice::7.12 | 7.12 User Documentation and Training |
| gamp-5-good-automated-manufacturing-practice::7.13 | 7.13 System Support and Maintenance During Operation |
| gamp-5-good-automated-manufacturing-practice::7.14 | 7.14 System Replacement and Retirement |
| gamp-5-good-automated-manufacturing-practice::7.2 | 7.2 Supplier Good Practices |
| gamp-5-good-automated-manufacturing-practice::7.3 | 7.3 Supplier Quality Management System |
| gamp-5-good-automated-manufacturing-practice::7.4 | 7.4 Supplier Requirements |
| gamp-5-good-automated-manufacturing-practice::7.5 | 7.5 Supplier Quality Planning and Prototyping |
| gamp-5-good-automated-manufacturing-practice::7.6 | 7.6 Sub-Supplier Assessments |
| gamp-5-good-automated-manufacturing-practice::7.7 | 7.7 Supplier Specifications |
| gamp-5-good-automated-manufacturing-practice::7.8 | 7.8 Supplier Design Reviews |
| gamp-5-good-automated-manufacturing-practice::7.9 | 7.9 Software Production and Configuration |
Chapter 8: Efficiency improvements – GAMP 5 - Good Automated Manufacturing Practice
| Code | Title |
|---|---|
| gamp-5-good-automated-manufacturing-practice::8.1 | 8.1 Establishing Verifiable and Objective User Requirements |
| gamp-5-good-automated-manufacturing-practice::8.2 | 8.2 Making Risk-Based Decisions |
| gamp-5-good-automated-manufacturing-practice::8.3 | 8.3 Leveraging Supplier Input |
| gamp-5-good-automated-manufacturing-practice::8.4 | 8.4 Leveraging Existing Information |
| gamp-5-good-automated-manufacturing-practice::8.5 | 8.5 Using Efficient Testing Practices |
| gamp-5-good-automated-manufacturing-practice::8.6 | 8.6 Employing a Well-Managed Handover Process |
| gamp-5-good-automated-manufacturing-practice::8.7 | 8.7 Managing Changes Efficiently |
| gamp-5-good-automated-manufacturing-practice::8.8 | 8.8 Anticipating Data Archiving and Migration Needs |
| gamp-5-good-automated-manufacturing-practice::8.9 | 8.9 Using Tools and Automation |
Development appendices D1 to D11 (requirements, configuration and design, software, testing, system descriptions, data migration, Agile, tools, distributed ledgers, AI and ML) – GAMP 5 - Good Automated Manufacturing Practice
| Code | Title |
|---|---|
| gamp-5-good-automated-manufacturing-practice::D1 | Appendix D1 Specifying Requirements |
| gamp-5-good-automated-manufacturing-practice::D10 | Appendix D10 Distributed Ledger Systems |
| gamp-5-good-automated-manufacturing-practice::D11 | Appendix D11 Artificial Intelligence and Machine Learning |
| gamp-5-good-automated-manufacturing-practice::D3 | Appendix D3 Configuration and Design |
| gamp-5-good-automated-manufacturing-practice::D4 | Appendix D4 Management, Development and Review of Software |
| gamp-5-good-automated-manufacturing-practice::D5 | Appendix D5 Testing of Computerized Systems |
| gamp-5-good-automated-manufacturing-practice::D6 | Appendix D6 System Descriptions |
| gamp-5-good-automated-manufacturing-practice::D7 | Appendix D7 Data Migration |
| gamp-5-good-automated-manufacturing-practice::D8 | Appendix D8 Agile Software Development |
| gamp-5-good-automated-manufacturing-practice::D9 | Appendix D9 Software Tools |
Management appendices M1 to M12 (planning, supplier assessment, QRM, categories, design review and traceability, quality planning, reporting, project change, documentation, retirement, infrastructure, critical thinking) – GAMP 5 - Good Automated Manufacturing Practice
| Code | Title |
|---|---|
| gamp-5-good-automated-manufacturing-practice::M1 | Appendix M1 Validation Planning |
| gamp-5-good-automated-manufacturing-practice::M10 | Appendix M10 System Retirement |
| gamp-5-good-automated-manufacturing-practice::M11 | Appendix M11 IT Infrastructure |
| gamp-5-good-automated-manufacturing-practice::M12 | Appendix M12 Critical Thinking |
| gamp-5-good-automated-manufacturing-practice::M2 | Appendix M2 Supplier Assessment |
| gamp-5-good-automated-manufacturing-practice::M3 | Appendix M3 Science-Based Quality Risk Management |
| gamp-5-good-automated-manufacturing-practice::M4 | Appendix M4 Categories of Software and Hardware |
| gamp-5-good-automated-manufacturing-practice::M5 | Appendix M5 Design Review and Traceability |
| gamp-5-good-automated-manufacturing-practice::M6 | Appendix M6 Supplier Quality Planning |
| gamp-5-good-automated-manufacturing-practice::M7 | Appendix M7 Validation Reporting |
| gamp-5-good-automated-manufacturing-practice::M8 | Appendix M8 Project Change and Configuration Management |
| gamp-5-good-automated-manufacturing-practice::M9 | Appendix M9 Documentation and Information Management |
Operation appendices O1 to O13 (handover, support services, monitoring, incidents and problems, CAPA, change and configuration, periodic review, backup, continuity, security, administration, archiving) – GAMP 5 - Good Automated Manufacturing Practice
| Code | Title |
|---|---|
| gamp-5-good-automated-manufacturing-practice::O1 | Appendix O1 Handover |
| gamp-5-good-automated-manufacturing-practice::O10 | Appendix O10 Business Continuity Management |
| gamp-5-good-automated-manufacturing-practice::O11 | Appendix O11 Security Management |
| gamp-5-good-automated-manufacturing-practice::O12 | Appendix O12 System Administration |
| gamp-5-good-automated-manufacturing-practice::O13 | Appendix O13 Archiving and Retrieval |
| gamp-5-good-automated-manufacturing-practice::O2 | Appendix O2 Establishing and Managing Support Services |
| gamp-5-good-automated-manufacturing-practice::O3 | Appendix O3 System Monitoring |
| gamp-5-good-automated-manufacturing-practice::O4 | Appendix O4 Incident Management and Problem Management |
| gamp-5-good-automated-manufacturing-practice::O5 | Appendix O5 Corrective and Preventive Action |
| gamp-5-good-automated-manufacturing-practice::O6 | Appendix O6 Operational Change and Configuration Management |
| gamp-5-good-automated-manufacturing-practice::O8 | Appendix O8 Periodic Review |
| gamp-5-good-automated-manufacturing-practice::O9 | Appendix O9 Backup and Restore |
Special interest appendices S1 to S6 (ASTM E2500, electronic production records, end user applications, patch management, organizational change) – GAMP 5 - Good Automated Manufacturing Practice
| Code | Title |
|---|---|
| gamp-5-good-automated-manufacturing-practice::S1 | Appendix S1 Alignment with ASTM E2500 |
| gamp-5-good-automated-manufacturing-practice::S2 | Appendix S2 Electronic Production Records |
| gamp-5-good-automated-manufacturing-practice::S3 | Appendix S3 End User Applications Including Spreadsheets |
| gamp-5-good-automated-manufacturing-practice::S4 | Appendix S4 Patch and Update Management |
| gamp-5-good-automated-manufacturing-practice::S6 | Appendix S6 Organizational Change |
Your Compliance Coverage
If you comply with GAMP 5 - Good Automated Manufacturing Practice, you already cover:
Maps to 91 other frameworks
Coverage is not the same as your position
This page shows what GAMP 5 - Good Automated Manufacturing Practice overlaps with in general. Where your organisation actually stands, against the standard you are going for and the certifications you already hold, is a different question. Same graph and the same recorded refutations, scoped to you rather than to a pair.
The Compliance Position Diagnostic, $5,000 fixed, ten business daysWhat is GAMP 5 - Good Automated Manufacturing Practice and who does it apply to?
GAMP 5 - Good Automated Manufacturing Practice is a compliance framework from International (pharmaceutical, biotechnology and medical device industry guidance) with 11 domains and 113 controls. GAMP 5 (Good Automated Manufacturing Practice 5) is the INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING (ISPE) flagship guide for Computerised Systems Validation in GxP-regulated environments (pharmaceutical + medical device + biotech + healthcare manufacturing + laboratories). Current edition GAMP 5 SECOND EDITION published July 2022 + supersedes the 2008 First Edition. KEY CONCEPTS: (a) RISK-BASED APPROACH - effort proportional to risk + complexity + regulatory impact; (b) LIFE CYCLE APPROACH - V-Model lifecycle with Specification + Verification phases mirrored; (c) CRITICAL THINKING - applying judgment over checkbox compliance; (d) LEVERAGE SUPPLIER INVOLVEMENT - reduce duplication via supplier qualification + documentation reuse + audit; (e) SCALABILITY - approach scales from small bench instruments to enterprise ERP/MES; (f) GxP regulatory alignment - 21 CFR Part 11 (FDA Electronic Records + Electronic Signatures) + EU Annex 11 (Computerised Systems) + ICH Q9 Quality Risk Management + ICH Q10 Pharmaceutical Quality System + FDA Computer Software Assurance (CSA) 2023 Draft Guidance. 5 SOFTWARE CATEGORIES (Appendix M4): Category 1 INFRASTRUCTURE (operating systems + databases + network); Category 2 was deprecated in 1st Edition; Category 3 NON-CONFIGURED PRODUCTS (commercial off-the-shelf); Category 4 CONFIGURED PRODUCTS (commercial with configuration); Category 5 CUSTOM APPLICATIONS (in-house developed). 2ND EDITION (2022) UPDATES: AI + machine learning systems; cloud + SaaS; agile + iterative development; DevOps; data integrity by design; explicit critical thinking emphasis; data integrity ALCOA+ deepening; computer software assurance (FDA CSA Draft Guidance 2022) alignment + replacing some traditional CSV. APPLICATION: typical implementation includes URS (User Requirements Specification) + FS (Functional Specification) + DS (Design Specification) + IQ (Installation Qualification) + OQ (Operational Qualification) + PQ (Performance Qualification) + Traceability Matrix + Risk Assessment + Change Control + Periodic Review + Data Integrity Controls + Decommissioning. AUDITORS: FDA + EMA + MHRA + PMDA + Health Canada + Brazilian ANVISA + China NMPA + other regulators inspect against GAMP 5 + Part 11 + Annex 11 + national regulations. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does GAMP 5 - Good Automated Manufacturing Practice actually require?
GAMP 5 - Good Automated Manufacturing Practice has 113 controls organised across 11 domains. The largest domains are Chapter 4: Life cycle phases (concept, project, operation, retirement) – GAMP 5 - Good Automated Manufacturing Practice (20 controls), Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice (20 controls), Chapter 7: Supplier activities (products, applications, services and the supplier good practices) – GAMP 5 - Good Automated Manufacturing Practice (14 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of GAMP 5 - Good Automated Manufacturing Practice do I already cover?
GAMP 5 - Good Automated Manufacturing Practice maps to 91 other compliance frameworks. The top mapping partners are ISO 13485:2016 (26% coverage), Annex 11 to EU GMP - Computerised Systems (25% coverage), IEC 62304:2015 Medical Device Software Lifecycle Processes (15% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I implement GAMP 5 - Good Automated Manufacturing Practice?
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