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Issue link: https://lifescienceleadermag.epubxp.com/i/183480
Contract Manufacturing Roundtable O'Brien: There are various indicators that can prompt a closer look at specific aspects of an operation, most notably, when issues arise that are not immediately communicated to the customer. Although oftentimes well-intentioned, when the vendor tries to fix a particular problem itself in order to avoid bothering the customer, negative consequences can follow. In our view, best practice is to communicate the issue immediately, while proposing corrective actions and/or a performance improvement plan in order to ensure that the right next steps are taken. When this process does not occur, the problem is often compounded, creating larger issues that could necessitate closing down the operation and shifting work elsewhere. ment, including expected actions, timing and ongoing monitoring. It is useful to share your own objectives and drivers for cost reduction, increased productivity and real-time involvement in production planning and process data, and to similarly understand strategic drivers for your CMO. This common understanding enables both parties to assume responsibility for continuous improvement. Introducing a Commercial Facility for TodayÕs Market UPM PharmaceuticalÕs new 500,000 square foot commercial facility in Bristol, Tennessee serves customers with large-scale manufacturing capabilities for solid oral dosage tablets and capsules, as well as semi-solid creams and ointments. KEY SITE FEATURES: • 500,000 square foot manufacturing facility • 70,000 square feet of general warehouse storage • 7,400 square feet of controlled substances storage • Excellent regulatory inspection history (DEA-licensed) • Comprehensive tech transfer support • Pilot plant with scale-up capacity • Analytical and microbial testing laboratories with dedicated suites for potent compounds To learn more, visit www.upm-inc.com or call +1 410 843 3738. WINNER NNOVA TION PRODUCTIVITY REGULATORY WHAT INITIATIVES SHOULD A CMO BE IMPLEMENTING TO ACHIEVE OPEX AND WHY? Bruno: CMOs must understand their manufacturing processes and their capabilities. Looking at each step of the process and seeing what improvements can be made and how they can affect the outcome is critical. A 50 percent improvement in the yield may sound great, but if it makes a marginal improvement in the operation, I wasted my time and effort. The FDA is telling us today that if we have a better understanding of what we are doing, which means more work upfront, there will be a greater reward (ability to implement improvements quicker) in the end. What CMOs should have is reasonable targets with rewards for getting there and an understanding of what happened along the way. Sometimes we need to consider failure as success. Increasing yields or reducing production time may not be possible. Understanding this could yield benefits in the long run. Casebier: Better estimation of resources needed for preproduction leads into scheduling of suite and plant time, as well as more surety of processes and simplification of procedures. CMOs tend to be confident and aggressive at the beginning of a project/ relationship but become far more conservative and unwilling to push projects through as time goes on. Several I have worked with have what appear to be unnecessary bureaucracies and paperwork load. Kempinski: Initiatives that bring client visibility in the following areas are desired: inven- 14 The CMO Leadership Awards 2013