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With modern automation and information technology solutions implemented in pharmaceutical manufacturing, process data, and material attributes gathered during the different manufacturing steps are available in almost real-time. In order to have these complex and heterogeneous data structures available at the manufacturer’s fingertips, there are many opportunities and ways to exploit and utilize this data also for routine process trending or even as part of the process control strategy. One option that proved to be successful and efficient is the use of multivariate tools such as multivariate statistical process control which reflects the complex and dynamic process information and offers a simple and effective way of visualizing the evolution of the process. This information can be readily available for all the members involved in the manufacturing chain, from operators, to process experts and process engineers. In this chapter, different application areas are illustrated by case studies covering small- and large-molecule manufacturing. The presented case studies are related to the support of quality by design controls strategies, feedback control loops, and process improvements. Further, the implementation and lifecycle management aspects starting from the qualification through to implementation and maintenance aspect will be elaborated on. |
