Although (2008, updated 2022) is now current, many regulated companies still reference GAMP 4 because:
GAMP (Good Automated Manufacturing Practice) is a set of guidelines for automated systems in pharmaceutical manufacturing. It focuses on ensuring that automated systems are designed, installed, and operated in a way that ensures product quality and patient safety. gamp 4
Not all systems require the same level of rigor. GAMP 4 categorized systems based on their complexity and potential product/patient risk. Although (2008, updated 2022) is now current, many