Engineering Considerations on Modeling for Pharmaceutical Process Analytical Technology (Pat) Applications

Recent FDA presentations and media reports indicate that process understanding is critical to enhance manufacturing efficiency and reduce the likelihood of producing products of poor quality [1]. The FDA’s Process Analytical Technology (PAT) Guidance [2] also highlights the importance of process understanding and process control. Focusing on pharmaceutical manufacturing processes may open up unprecedented opportunities and challenges for engineering disciplines, such as applying fundamental engineering principles to process/product design, process scale-up, process monitoring, and process control. Process modeling as an enabling tool for linking various stages in the manufacturing pipeline will play a key role during the implementation of PAT in pharmaceutical development, manufacturing, and quality assurance, and is also being reflected in recent ICH (International Conference on Harmonization) Guidelines Q8 [3] and Q9 [4]. Although other industry sectors have been adopting various process control tools as an essential measure for achieving and ensuring Quality-by-Design for many years, using engineering modeling as the foundation for process control remains a significant challenge for the pharmaceutical industry. In this regard, specific case studies can be very helpful as they may not only have a positive impact on the pharmaceutical practitioners, they may also convince the pharmaceutical community to embrace engineering principles and practices. These practices have proven extremely valuable in the process development, scale-up, and manufacturing domain.