Abstract
This first chapter introduces the quality-by-design (QbD) concept and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and can eventually enable real-time release, regardless of the formulation type. Several guidelines on pharmaceutical development, quality risk management, and pharmaceutical quality systems are presented that are applicable throughout the product life cycle. Design space appointment and control strategies for risk management are introduced. The meaning of the QbD concept is presented from academic, regulatory, and industrial points of view. Several illustrative examples are provided to facilitate the understanding of the QbD concept and the ease of its application.
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