QbD in Mobile Production Scenarios: Progress Toward a Multistage PAT Strategy for Pharmacy on Demand

Quality by Design strategies in the area of API production largely focus on definition of design space for reactions for development and commercial processes followed by traditional isolation, sampling and off-line release. PAT monitoring utilized in development has generally been removed when processes enter the commercial manufacturing facilities or is used “for information only” purposes. Continuous, on-demand production strategies require the PAT monitoring and quality control of intermediate as well as crude API solutions in order to release materials for purification. In addition PAT strategies can be envisioned which could eventually remove some end-product testing for API, thus allowing on-demand release to accompany the on-demand production. The talk will focus on potential PAT and control strategy opportunities that will facilitate the eventual move toward RTRT of CQAs for API.