Overview of Good Automated Manufacturing Prac...

Overview of Good Automated Manufacturing Practice (Gamp 5)

Author Name : Gadge Seema, Pingale Rupesh, Nimse Kshama, Jadhav Sachin

ABSTRACT The guidelines of GAMP-5 release in Feb 2008 at ISPE (International Society for Pharmaceutical Engineering) in Manufacturing Excellence Conference. The purpose of the guidelines is to “provide a cost effective framework of good practice to give surety that computerized systems are fit for use and compliant with regulation.” Understanding the product and process is critical in determining system requirements and for making science and risk-based decisions to give surety that the system is “fit for use.” In determining “fit for use,” attention should be focused on “those aspects that are critical to patient safety, product quality, and data integrity.” Present guide is GAMP – 5 “A Risk-Based Approach”, FDA has applying risk and impact assessment, including validation of Electronic Data Management System (EDMS), categorization of system components and supplier assessment as a validation strategy. GAMP 5 is an automated computer system validation testing tools used to improve test efficiency and effectiveness.