Model-Based Process Control in API Manufacturing: A QbD-Vantage!

Quality-by-design (QbD) is a fundamental tenet of any process development group that is engaged in designing robust and efficient processes for commercial API manufacture. The quest for QbD in API synthesis culminates into extensive knowledge generation on various unit operations such as reactions, purifications, and isolations, in the form of fundamental mechanistic understanding, multi-parameter (multivariate) interactions and models. Models bring in predictive ability that is valuable in streamlining R&D work and to develop scientifically sound design space for process parameters. A model could also be applied as an element of process control that satisfies quality requirements or as a process monitoring/trending tool in manufacturing. Presented is a case-study developed for evaluation of model-based process control in API manufacturing.