Chapter 4 - Pharmaceutical product development: A quality by design (QbD) approach

Abstract

Quality by design (QbD) refers to a scientific approach to product manufacturing that could improve performance, provide regulatory relief and versatility, and deliver substantial business benefits over the product life cycle. It encourages both industry and the FDA to move towards a more research, risk-based, comprehensive, and constructive approach to pharmaceutical production. The International Conference on Harmonization and the United States Food and Drug Administration (USFDA) illustrated the concepts and applications of QbD in pharmaceutical production in their advice to the industry. QbD attributes are discussed in a question-based analysis established by the USFDA Chemistry, Manufacturing and Control Section of Abbreviated New Drug Applications. The QbD principles, when applied, lead to significant product growth, subsequent prompt regulatory approval, reduce the exhaustive burden of validation and substantially reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessment, design space, control strategy, product lifecycle management and continuous improvement are addressed in order to understand the performance of dosage forms within the design space. The implementation of QbD in the formulation and design of drugs is based on a clear understanding of the sources of uncertainty and the manufacturing process. This analysis underlines the significance of QbD in inculcating a science-based approach to the production of pharmaceutical products.