Definitions and Scope of Key Elements of QbD

The concept of Quality by Design (QbD) has been applied to the development of small-molecule pharmaceuticals and is increasingly being applied to the development of biopharmaceuticals. The successful implementation of a QbD approach requires a good understanding of its key elements. These include the quality target product profile (QTPP), critical quality attributes (CQAs), critical material attributes (CMAs), risk assessments, design space, critical process parameters (CPPs), a comprehensive control strategy, and lifecycle management. In this chapter, we have provided the basic definitions and considerations necessary to deliver these key elements for biopharmaceutical development.