(310b) Building Process Robustness and Flexibility Through Implementation of QbD Methodologies

Effective Quality by Design (QbD) achieves a thorough understanding of processes via a systematic set of development activities guided by a comprehensive risk assessment.  The output of the thorough process understanding is a well-defined control strategy that achieves consistent delivery of a product's critical quality attributes (CQAs). Elements of this control strategy include raw material specifications, in process testing, and control via design space definition; moving away from the prior methodology of "testing in quality."

This talk focuses on the QbD development work related to a drug substance crystallization process. Factors from the risk assessment were investigated in a multi-factor Design of Experiments (DOE), with design space ranges selected such that the output of the DOE demonstrates the following: the process ensures all drug substance CQAs are achieved, the process is robust and well understood, and the process is flexible to accommodate the supply chain. Responses from the DOE were statistically analyzed to evaluate their impact on drug substance CQAs across the design space. The results will show that all drug substance CQAs were achieved across the entire design space, demonstrating a robust process that delivers quality API.