Essentials of GAMP-5: A quality risk-based approach to compliant GxP computerized systems

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

P.Lalasa, A.Kailash, N.Vishal Gupta and H.V.Raghunandan

Posters: Pharmaceut Reg Affairs

Abstract :

The new GAMP-5 guidelines were released February 2008 at the ISPE Manufacturing Excellence Conference in Tampa, Florida. These guidelines are the latest, up-to-date thinking in the approach to validation of GxP computerized systems. The purpose of the guidelines is to ?provide a cost effective framework of good practice to ensure that computerized systems are fit for use and compliant with regulation.? There are five key concepts to GAMP 5: ? Product and Process Understanding ? Lifecycle approach within QMS ? Scalable Lifecycle Activities ? Science Based Quality Risk Management ? Leveraging Supplier Involvement Why GAMP 5 Now? Since the release of GAMP 4 in 2001 the regulatory bodies had made significant updates in their thinking and approach to regulatory compliance. These changes include; ? FDA cGMPs for the 21st Century initiative and associated guidance promoting science-based risk management ? ICH Guidance Q8, Q9, and soon to be released Q10, which is expected to promote science based risk management ? PIC/S Guidance Practice for Computerized Systems in Regulated GxP Environments which clarify regulatory expectations GAMP also designed GAMP 5 to be compatible with IEEE standards, ISO 9000 and 12207, IT Infrastructure Library (ITIL), and other international standards. GAMP also wanted to: ? Focus attention on computerized systems that most impact patient safety, product quality, and data integrity ? Leverage supplier activities to the maximum possible extent while ensuring fitness for intended use ? Recognize that most computerized systems are now based on configurable packages

Biography :

P.Lalasa is a student of JSS College of Pharmacy, JSS University, Mysore, Karnataka, India. She has completed her B.Pharm from JSS College of Pharmacy under RGUHS, Bangalore, Karnataka, India during 2007-2011. Presently she is pursuing M.Pharm in Pharmaceutical Quality Assurance in the same college. Her areas of interest are Quality Management System, GMP etc.