Gamp Classification <2026>

The GAMP (Good Automated Manufacturing Practice) 5 categorization system (from ISPE) classifies computerized system components into and Hardware Categories (1-2) . The goal: determine the level of validation rigor based on risk and complexity.

Understanding GAMP 5 Software Categories In the pharmaceutical and life sciences industries, ensuring that computer systems are fit for their intended use is not just a best practice—it is a regulatory requirement. (Good Automated Manufacturing Practice, 5th Edition), published by the International Society for Pharmaceutical Engineering (ISPE) , provides a risk-based framework for the validation of automated systems. A core component of this framework is the classification of software into specific categories, which dictates the level of validation effort required. What is GAMP Classification? gamp classification