Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product.

The 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 products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry.

Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material 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 methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities.

Highlights

• Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications
• Chapters are devoted to applications of QbD methodology in three main processing sectors--drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing
• Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes
• The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

GINTARAS.V. REKLAITIS, PhD, is Professor of Chemical Engineering and Industrial & Physical Pharmacy at Purdue University, member of the U.S. National Academy of Engineering, and the Deputy Director of the NSF Engineering Research Center on Structured Organic Particulate Systems.

CHRISTINE SEYMOUR, PhD, is Director in Global Regulatory Chemistry, Manufacturing & Controls at Pfizer Inc, the 2018 President of AIChE, and a Director in AIChE's Society for Biological Engineering.

SALVADOR GARCÍA-MUNOZ, PhD, is a Senior Engineering Advisor in Process Modeling and Optimization in Small Molecule Development at Eli Lilly and Company.