alexa
Reach Us +1-217-403-9671
Essentials Of GAMP-5: A Quality Risk-based Approach To Compliant GxP Computerized Systems | 7446
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
Open Access

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations
700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)
All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission System of respective journal.

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

2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

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

Posters: Pharmaceut Reg Affairs

DOI: 10.4172/2167-7689.S1.007

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.
Top