Claire Twomey, Technical Operations, Eli Lilly, Dunderrow, Co. Cork, Kinsale, Ireland, Helena Ryan, Science & Technology Team, Eli Lilly, Dunderrow, Co. Cork, Kinsale, Ireland, Niamh Warren, Process Engineering, Eli Lilly, Dunderrow, Co. Cork, Kinsale, Ireland, and Kevin D. Seibert, Cpr&d, Eli Lilly & Co., DC 4813, 1400 W. Raymond St., B110, Indianapolis, IN 46221.
Consistent with the science and risk based strategies associated with Quality by Design initiatives, routine process capability has been utilized as a means of establishing criticality of process parameters for a new product launch in a manufacturing facility. Prospective analysis of control systems was used to ensure assumptions made by development for routine process capability were consistent with actual system performance. Where necessary, control tuning was leveraged to reduce systematic variation and ensure equipment was adequately capable of the appropriate level of control required by the criticality assessment.