What is GAMP?
GAMP stands for Good Automated Manufacturing Practice. It is a guideline that describes how automated systems should be validated in regulated environments such as the pharmaceutical industry.
GAMP helps demonstrate that systems and software are fit for purpose, reliable and compliant for the production of medicines or medical devices.
The guideline is maintained by ISPE (International Society for Pharmaceutical Engineering) and is closely linked to GxP, FDA, GMP and CSV.
🎯 The purpose of GAMP
- Ensuring product quality and patient safety
- Risk-based validation of automation and IT systems
- Demonstrability of compliance with regulations such as EU GMP Annex 11, 21 CFR Part 11
- More efficient validation through a reusable approach and classification
🧱 Key principles of GAMP
| Principle | Explanation |
|---|---|
| Lifecycle approach | Validation from design through to decommissioning |
| Risk-based working | Focus on impact on product quality and patient safety |
| System categorisation | Classification of software and hardware determines the validation effort |
| Documentation and traceability | All steps must be demonstrable, repeatable and auditable |
| Supplier assessment | Software supplier reliability and documentation form part of validation |
🖥️ GAMP categories for software systems
| Category | Type of system | Example |
|---|---|---|
| 1 | Information (non-configurable) | Operating system, standard database |
| 3 | Non-configured software | SCADA, LIMS, PLC firmware |
| 4 | Configured software | MES, WMS, ERP with settings |
| 5 | Custom software | Bespoke batch application, algorithm |
The higher the category, the more extensive the validation required.
📄 Examples of GAMP documentation
- User Requirements Specification (URS)
- Functional & Design Specs
- Risk Assessment
- Test plans (IQ, OQ, PQ)
- Traceability Matrix
- Change Control documentation
- Periodic reviews (e.g. requalification)
🧪 GAMP vs. CSV
| GAMP | Computerised System Validation (CSV) |
|---|---|
| Guideline for the approach | Specific validation process for a system |
| Includes lifecycle model and best practices | Focused on executing tests and gathering evidence |
| Applied within a GxP context | Operational component of the GAMP approach |
✅ Benefits of GAMP
- Standardised validation approach
- Efficiency and reusability in projects
- Demonstrable compliance with legislation and standards
- Risk reduction and improved quality
- Foundation for Audit, QMS and Change Management
📌 In summary
GAMP is the international guideline for validating automated systems in regulated production, and helps demonstrate that your systems are safe, reliable and compliant.