Pharmaceutical Process Design and Management [Paperback]

A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.Using their considerable knowledge and experience of pharmaceutical manufacturing, the authors take you through the various elements involved in a process: man, machine, materials, method and environment. They discuss quality control and assurance, tools for quality improvements and ways of designing the process to effectively manage outgoing quality. They believe that for processes to run successfully, all employees must be problem-solvers. With the right process design, every problem can be broken down into solvable elements. Pharmaceutical Process Design and Management shows you how to do just that.Kate McCormick has extensive experience in pharmaceutical manufacturing, having worked with companies and regulators worldwide. She has published several textbooks and articles, edited GMP Review from 2004 to 2011 and is a former education advisor for ISPE. McCormick hls