Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development

Quality by Design (QbD) and Analytical Quality by Design (AQbD) are covered in this book, which is written by twenty-five authors from academia, the pharmaceutical industry, and Pharmacopeias worldwide. It covers the fundamentals and applications of QbD and AQbD in a practical and didactic manner, including the motivation for implementation, major elements, life cycle and regulatory perspectives, DOE theory, modelling and data treatment, practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms, and advanced statistical approaches and DOE methods for extraction studies of bioactive compounds.

Format: Hardback
Length: 266 pages
Publication date: 14 July 2023
Publisher: Springer International Publishing AG

This comprehensive monograph, authored by twenty-five experts from academia, the pharmaceutical industry, and Pharmacopeias worldwide, provides a practical and didactic exploration of Quality by Design (QbD) and Analytical Quality by Design (AQbD). The book begins by highlighting the urgent need for implementing the QbD framework in pharmaceutical development and defining its key elements, including the Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs), and the importance of multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives is also discussed. Three chapters are dedicated to DOE theory, covering screening to optimization designs. Additionally, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process development are extensively explored, including input process variables, material attributes, intermediate, and final quality attributes for various dosage forms. Analytical Quality by Design (AQbD) is thoroughly explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR), and the life cycle approach, considering compendial and regulatory perspectives. A detailed example of a new chromatographic method for quality control of a pharmaceutical topical product based on the AQbD procedure is provided. Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are presented. The book offers a wealth of information and is a valuable resource for researchers, practitioners, and students in the field of pharmaceutical development.

Dimension: 235 x 155 (mm)
ISBN-13: 9783031315046
Edition number: 1st ed. 2023