Kevin D. Seibert, Chermical Product Research and Development, Eli Lilly & Co., 1400 W. Raymond St., Indianapolis, IN 46221, Shanthi Sethuraman, MS&T Statistics, Eli Lilly & Co., 1400 W. Raymond St., Indianapolis, IN 46221, and Chad Wolfe, CPR&D, Eli Lilly & Co., 1400 W. Raymond St., Indianapolis, IN 46221.
Consistent with the Quality by Design initiative, routine process capability can be used to establish the criticality of process parameters for an API process in relation to its impact on the CQAs. In addition, routine process capability can also be used to assist in the mapping of the design space and control space for an API process prior to the installation and validation. An example depicting the consistent assignment of criticality to process parameters, as well as a DOE driven mapping of the design space and control space will be presented.