ABSTRACT
The overall goal of adequate process characterization for commercial manufacturing processes is to ensure efŒcient and successful process validation and the assurance of consistent process performance [2]. More speciŒcally, process characterization provides:
• An understanding of the role of each process step, such as an understanding of where impurities are cleared during a particular puriŒcation step
4.1 Introduction .................................................................................................... 63 4.2 Resources and Timing for Process Characterization Studies .........................64 4.3 Precharacterization Work ...............................................................................64
