GAMP® 5 aims to provide a comprehensive explanation of how pharmaceutical companies should validate their computer systems. In practice, this means that these recommendations apply both to the users of automated pharmaceutical products, as well as the manufacturers who create and market them.

What is the use of GAMP 5?

In a nutshell, GAMP®5: A Risk-Based Approach to Compliant GxP Computerized Systems provides a framework for the risk-based approach to computer system validation where a system is evaluated and assigned to a predefined category based on its intended use and complexity.

What is the main objective of GAMP?

The goal of the community is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry. The GAMP COP organizes discussion forums for its members. ISPE organises GAMP-related training courses and educational seminars.