Process Modeling and Assessment Tools for Simulation, Risk Management and Design Space Development of Integrated Pharmaceutical Manufacturing Processes

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Summary The process model and simulation system of the integrated manufacturing process are developed and validated with pilot process of a collaborator for solid based drug products. The deterministic process models are supplemented and adjusted with multivariate statistical process models to take process uncertainties into account. With this simulation tool, one can conduct critical tasks including risk assessment, control strategy determination, identification of critical material and process attributes, and eventually understanding relationship between raw material attributes and process parameters on final product qualities. The process models are imbedded in Monte Carlo simulation to determine design space while considering probability of process failure. The design space with failure probability are used for determining optimum operating ranges of the key process parameters while minimizing Out-Of-Specification (OOS) of Critical Quality Attributes (CQA). The simulation tool will provide significant benefits for regulatory sciences.