Achieving Quality and Compliance Excellence in Pharmaceuticals
July 4, 2012
-- 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.
Over twenty top experts in their respective fields have come together from USA, Europe and Asia to fill the knowledge gap that was existing in this fields for some years.
This is a practical how-to book that emphasizes easy implementation of quality and compliance strategies that pharmaceutical manufacturers can directly benefit from.
"The changing regulatory environment encourages a risk-based and performance-
governed compliance approach based on an agile quality framework. Such an approach is fundamental to maintaining competitiveness, irrespective of location and cost base. This book not only encourages and details the application of these modern quality paradigms in a single guide, it is also an aide and an encouragement for those in industry who wish to learn from the best, continually improve, embrace advancement of science and benchmark themselves. The high calibre of the authors and the diligence of the editor assure comprehensive, current and exceedingly high quality of the contents." - from the Foreword in the book by Siegfried Schmitt, PhD, Paraxel, UK
Hardbound 664 pages, ISBN 9788190646789, First Edition 2012
Editor: Madhu Raju Saghee (M.Sc.) is working in corporate quality department at Gland Pharma, in Hyderabad, India. In this position, he is responsible for implementing a robust quality system, ensuring regulatory compliance and involved in qualification and validation of sterile and aseptic manufacture for parenterals. Madhu is also a Director for Indian region for Pharmaceutical and Healthcare Sciences Society (PHSS).
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