QbD Based Formulation Services —The DPT Labs Approach

This paper describes the approach and benefits of using DPT Labs’ QbD Formulation service and follows the previous paper in our Thought Leadership Series, “What is QbD and Why Should You Care?”

DPT Labs’ QbD Formulation service leads a customer through a rigorous process that minimizes risks to development success. Beginning with a Quality Target Product Profile (QTPP), the service further examines and narrows down formulation choices by conducting a pre- Formulation study, followed by formulation development (to include preliminary stress testing) and analytical method development, ending with an informal stability study.