Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture | AIChE

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture


October, 2017





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.


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 has enjoyed participating in AIChE leadership for more than 25 years. She had the great honor of being the 2018 AIChE President. Christine was the founding Chair of the Pharmaceutical Discovery, Development, and Manufacturing Forum and was the Secretary of the AIChE Board of Directors, on the Society of Biological Engineering (SBEE) Board of Directors, Chair of EBPC, an AIChE Board member, Spring Meeting Program Chair, Process Development Division Chair, and a Process Development Division Formation Committee member. Most of all, Christine has valued the friendships she...Read more

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