Glossary Term
Good Automated Manufacturing Practices (GAMP)
Definition
Good Automated Manufacturing Practices (GAMP) is a set of guidelines and best practices designed to ensure the quality, integrity, and regulatory compliance of automated systems used in the manufacturing of pharmaceutical and medical device products. Originating from the International Society for Pharmaceutical Engineering (ISPE), GAMP focuses on validating computer systems and automation technologies within regulated environments.
Relevance to the MedTech Industry
GAMP ensures that automated systems used in the production and quality assurance of medical devices function reliably and meet stringent regulatory requirements. It reduces risks associated with system failures, ensures product consistency, and maintains compliance with standards like FDA’s 21 CFR Part 11 and ISO 13485.