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Issue link: https://lifescienceleadermag.epubxp.com/i/183480
Contract Manufacturing Roundtable tory controls, quality management of materials sourcing, production plans and schedules, real-time production data, compliance findings, and risk assessment. Movement to automated data collection processes is important to provide the real-time access needed to engage in continuous improvement in quality, compliance, plant performance, etc. and to better afford the identification of true key performance indicators (KPIs) for ongoing monitoring. A set of shared continuous improvement initiatives needs to be defined and tracked over time; where practical, it may be helpful to benchmark against similar processes within the CMO or to processes placed with other CMOs. SHARE AN EXAMPLE OF AN INITIATIVE BEING IMPLEMENTED EITHER EXTREMELY WELL OR THE CONVERSE. Casebier: In general, the best implementation of programs or initiatives is accomplished by small, competent, and impassioned teams. I emphasize small, because once consensus of a large group becomes a priority smooth implementation and speed are lost. Focusing on the goal and how to get there is the most important aspect, as opposed to minimizing liabilities first. Being mindful of potential pitfalls is good, but the larger the group, the more focused on liabilities it becomes, either by the need for everyone to contribute something, or by statistical paranoia that emerges with a large enough population. What is needed is an important compelling vision combined with marching orders to technically competent people with a drive to exceed that vision. Keltner: An API manufacturing process had failed at an outsourced manufacturer, primarily due to a tricky material testing and validation sequence for moisture control. The manufacturer was unable to suggest solutions, and setting up adequate communication was difficult, partially due to culture and language barriers. Another manufacturer was selected by the CMO. Both were located outside North America. To ensure that there was maximal likelihood of detection of process errors and maximal potential for interaction, webcams and webenabled humidity sensors were mounted in the three critical manufacturing suite areas and available to staff 24/7 on any web-enabled device. On four occasions during the first API run, impending errors were detected and corrected before they occurred, likely saving almost nine months on the critical path to NDA submission. The CMO Leadership Awards 2013 15