Quality by Design: Industrial Case Studies on Defining and Implementing Design Space for Pharmaceutical Processes Part 1

A key challenge in successfully implementing Quality by Design (QbD) is achieving a thorough understanding of the product and the process. This knowledge base must include understanding the variability in raw materials, the relationship between the process and the critical quality attributes (CQAs) of the product, and finally the relationship between the CQAs and the clinical safety and efficacy of the product.