Glossary
GAMP 5
What is GAMP 5?
GAMP 5 (Good Automated Manufacturing Practice) is a set of guidelines developed by the International Society for Pharmaceutical Engineering (ISPE) to ensure the quality and compliance of computerized systems used in the pharmaceutical industry. It provides a framework for the validation and qualification of automated systems throughout their lifecycle.
What are the key Principles of GAMP 5?
- Risk Management: GAMP 5 emphasizes a science-based risk management approach to system validation and qualification. It encourages organizations to identify and assess potential risks associated with automated systems.
- Lifecycle Approach: The framework promotes a lifecycle approach to system development and maintenance, recognizing that systems evolve over time and advocating for validation activities to be conducted throughout the system’s lifecycle.
- Supplier and Internal Audits: GAMP 5 stresses the importance of auditing suppliers and internal processes to ensure compliance and quality.
- Documentation and Traceability: The guidelines emphasize the need for comprehensive documentation and traceability throughout the system’s lifecycle.
- Change Management: GAMP 5 encourages organizations to have change management processes and robust procedures in place to ensure that changes do not compromise product quality or patient safety.
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What are the benefits of GAMP 5?
- Ensures regulatory compliance with various authorities like the FDA and EMA
- Maintains data integrity and consistently produces high-quality products
- Mitigates risks associated with automated systems
- Improves efficiency in system development, implementation, and maintenance
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How is GAMP 5 related with 21 CFR Part 11 and EU Annex 11?
GAMP 5 provides a methodology for implementing the requirements of 21 CFR Part 11 (US FDA) and EU Annex 11, which define the criteria for electronic records and electronic signatures.
