Context: GAMP 5 (Good Automated Manufacturing Practice) is a guide published by the International Society for Pharmaceutical Engineering (ISPE). It describes a risk-based approach to developing, operating and maintaining GxP-relevant computerized systems so that they are fit for their intended purpose.
Why it matters: Such systems support manufacturing, quality control and data management, among other areas. GAMP 5 helps align appropriate lifecycle activities and evidence with the actual product, patient and data integrity risk.
Guiding principles:
- Quality and patient safety as the starting point for risk assessment.
- Scalable lifecycle activities and documented evidence, matched to risk and system complexity.
- Clear requirements, supplier assessment and controlled changes across the entire system lifecycle.
- Verification focused on functions with GxP relevance.
Distinction: GAMP 5 is not a statutory or regulatory requirement but a recognised industry guide. It supports the risk-based interpretation of applicable GxP requirements but does not replace them.
Short version: GAMP 5 supports a risk-based, lifecycle-oriented approach to GxP-relevant computerized systems.
Further reading: