The Development of a Rational Testing Strategy using QbD: A Case Study

A control strategy is required for every product to ensure product quality. The elements that comprise the control strategy include controls associated with the environment, procedures, incoming raw materials, process parameters, and testing. The use of risk assessment tools facilitates the development of the control strategy, particularly with respect to parametric and testing control.
A case study will be presented in which a risk ranking filter was established to guide the development of a rational testing strategy for a liquid monoclonal antibody product. Examples of the application of the tool for specific CQAs will be discussed along with health authority feedback regarding the resulting testing strategy.