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Achieving Quality and Compliance Excellence in Pharmaceuticals 1st Edition

2,800.00 2,380.00

ISBN 9788190646789
Presentation Hardbound, 664 Pages
Edition 1st Edition 2012
Weight 1.15 Kg
Author Madhu Raju Saghee
Price INR 2800
Availability  In Stock
SKU: 9788190646789 Category:

Description

In todays contemporary pharmaceutical industry, the focus has slowly but surely shifted from the elusive research pipeline and latest blockbuster molecules to current processes, efficiencies and manufacturing systems. A path most often taken by manufacturers today in this direction includes improving their overall quality and compliance efforts. This results in a two-pronged approach of minimizing the litigation cost and concurrently improving the overall quality of the products and efficiencies in their processes and procedures. This book provides current thinking and approaches to achieving quality and compliance from top industry experts and is pioneering in bringing this wealth of information together in a single volume which will be of great use to the pharmaceutical industry. Compliance and quality issues have been comprehensively covered, from GMP requirements to deviation management, OOS and CAPA methodologies, QRM and QMS practical implementation, qualification and validation, records and documentation practices, latest GMP training techniques and performance metrics for compliance and detailed analysis of ICH guidelines for practical implementation. This book aligns with the FDA’s 21st century initiative and the ICH guidelines focused on quality risk management (ICH Q8, Q9, Q10 and Q11) and underpins the importance of science based decisions and risk evaluation as the centerpiece of compliance policy and execution. It provides a pragmatic framework for establishing a robust quality system. About the Editor Madhu Raju Saghee is working in corporate quality department at Gland Pharma. His areas of expertise include all aspects of quality and compliance for systems, processes, facilities and operations for drug products, particularly for sterile products. Madhu is also a volunteer for Pharmaceutical and Healthcare Sciences Society (PHSS) and acts as Director for Indian region. Madhu is the co-editor of the books ”Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices” and ”Cleanroom Management in Pharmaceuticals and Healthcare.” Madhu has a Master of Science in Microbiology. He is an active member of various industry associations, including PDA, PHSS and ISPE.

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