GAMP4 Compliance

Good Automated Manufacturing Practice. GAMP4 is an internationally accepted set of quality standards and practices for validating automated systems in pharmaceutical manufacture, including infrastructure control and compliance, calibration management, global information systems, compliant electronic records and signatures and computerized laboratory systems. The GAMP community is part of the International Society for Pharmaceutical Engineers (ISPE). GAMP is endorsed as good practice by both the United States Food and Drug Administration (FDA) and the European Pharmaceutical Inspection Cooperation Scheme (PIC/S).