Quality by Design for Biopharmaceuticals (eBook, PDF)
Principles and Case Studies
Redaktion: Rathore, Anurag S.; Mhatre, Rohin
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The concepts, applications, and practical issues of Quality by Design 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 indust...
The concepts, applications, and practical issues of Quality by Design 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.
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