Process Robustness in Pharmaceutical Manufacturing

Brief session description: In Quality-by-Design (QbD) process development, the "design space" is the quantified range of formulation and process inputs that will still yield "quality" product. The broader the design space, the more "robust" the process is - which is generally a good thing! Determination of critical process parameters (CPPs) and their effects on the critical quality attributes (CQAs) of the product is a key step toward better understanding overall process robustness and opportunities for continuous quality improvement in pharmaceutical manufacturing. We invite submissions detailing methods and case studies on quantifying and broadening the design space to improve process robustness. Examples of both drug substance and drug product manufacturing are of interest.