(160b) Stability In a QbD Framework

Multivariate Data Based Empirical models can be used to predict future product performance in terms of Stability, and anticipate product shelf life. So far Quality by Design is being used to assess the quality of a product at release based upon manufacturing data but this concept can be extended to investigate stability patterns based on multivariate interactions of raw material characteristics, manufacturing process parameters, and packaging characteristics. The DoEs for Design Space determination  could be planned to include stability studies. Process Understanding derived from such studies would lead to appropriate Control Strategy  that takes into account stability requirements