ISPE GAMP (Good Automated Manufacturing Practice)

ISPE GAMP (Good Automated Manufacturing Practice) provides guidelines for managing the development, validation, and maintenance of automated systems in the pharmaceutical and biotechnology industries. It ensures these systems are reliable, compliant with regulations, and ensure product safety and quality. The framework emphasizes risk-based approaches, clearly defined lifecycle phases, and best practices for documenting and validating automated processes. By following GAMP, companies can efficiently implement technology solutions that meet regulatory standards while maintaining consistent, safe, and effective manufacturing operations.