(375d) Achieving Manufacturing Flexibility and Product Quality Through Dynamic Design Spaces

Flexible manufacturing through dynamic design spaces?  Mechanistic models vs. empirical models? Quality by design provides opportunity for the pharmaceutical industry to apply multivariate modeling methods in defining design spaces. Modern approaches to process validation have led to interesting questions regarding the definition of design spaces. Is a design space best defined as the multivariate model that relates critical process parameters to critical quality attributes?  What combination of mechanistic and empirical modeling will provide an optimum design space while meeting current regulatory philosophy?  What are appropriate methods for managing model (design space) updates?  How are models or design spaces best verified?  What is the effect of scale on models that define design spaces?  What is a “significant” change in design space?  What are appropriate tolerances on a design space?  These and other current questions regarding design spaces will be considered by the author in discussing modern approaches to achieving manufacturing flexibility and optimizing product quality.