“Quality by Design (QbD)” is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. “Quality by Design: Perspectives and Case Studies” presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: • The understanding and development of the product's critical quality attributes (CQA) • Development of the design space for a manufacturing process • How to employ QbD to design a formulation process • Raw material analysis and control strategy for QbD • Process Analytical Technology (PAT) and how it relates to QbD • Relevant PAT tools and applications for the pharmaceutical industry • The uses of risk assessment and management in QbD • Filing QbD information in regulatory documents • The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, “Quality by Design” is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.
