QbD Beyond Manufacturing
Overview of Quality by Design
Quality by Design (QbD) is a well-known concept in regulatory circles. The FDA “strongly encourages” all ANDA applicants to use a Quality by Design approach. Similarly, the European Medicine Agency (EMA) has been pushing QbD concepts heavily in recent years. Quality by Design is the theory that quality should be designed into the final product and not just tested into it. QbD should be incorporated into every phase of development from the beginning and not just in the manufacturing process. By incorporating QbD principles, there are fewer complications and compliance issues because potential problems have been addressed before they exist. Problems that do arise are dealt with more systematically and therefore, more successfully. The goal of QbD is to be maximally efficient, agile and flexible while reliably producing high-quality pharmaceutical products without the need for extensive regulatory oversight.