Chapter 20 - Integrated Application of Quality-by-Design Principles to Drug Product and Its Control Strategy Development

Abstract

This chapter provides an integrated case study on the systematic application of quality-by-design (QbD) to product development and demonstrates the implementation of QbD concepts in the different aspects of product and process design for a drug product manufactured by a wet granulation process. Using a risk-based approach, the strategy for development entailed identification of product critical quality attributes (CQAs), assessment of risks to the CQAs and performing experiments to understand and mitigate identified risks. Quality risk assessments and design of experiments (DOEs) were performed to understand the quality of the input raw materials required for a robust formulation and the impact of manufacturing process parameters on CQAs. In addition to material property and process parameter controls, the control strategy includes use of process analytical technology (PAT), as well as conventional analytical tests, to control in-process material attributes and ensures quality of the final product.