Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Published: 
October, 2017
ISBN: 
978-0-470-94237-6
Pages: 
396

This book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality pharmaceutical products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes, and for providing the underpinnings for science-based regulation the pharmaceutical industry. Edited by three renowned researchers, the book is divided into three main sections.

The first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical modeling. The seven chapters in the second section present case studies. The last section discusses the needs for integrated tools and the status of the tools available for systematic data and knowledge management to support QbD.

Author(s): 

Salvador García-Muñoz

Salvador Garcia has wide expertise and deep knowledge in process and product design, process simulation and multivariate latent variable methods (PCA/PLS and others). Consulted and closely worked with a wide range of chemical industries. Has both experience in plant floor and in research environment with international exposure progressing projects in America and Europe. Speaker and organizer of international conferences and forums around the application of modeling technology for QbD. Salvador holds a Ph.D. in Chemical Engineering from McMaster University (Canada) a M.Sc. and a B.Sc. in...Read more

Christine Seymour, Ph.D.

Christine Seymour is serving on the AIChE Board of Directors. She has also been the Spring Meeting Programming Chair (2008), the Spring Meeting Programming Vice-Chair (2005), the Process Development Division Chair (2003-2005), and the Process Development Division Programming Chair (1999-2001). In addition to her role as an AIChE volunteer, Christine is an Associate Research Fellow in Global Chemistry and Manufacturing Controls (CMC) at Pfizer Inc. She leads the CMC regulatory strategy and implementation for a portfolio of projects across all phases of drug development and...Read more

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