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.
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 has qualifications in biochemistry, microbiology and business studies. Wylie McVay has extensive operations support experience in pharmaceutical quality control, quality assurance and post-approval regulatory affairs. McVay is a review board member of the Journal of Validation Technology and GxP Compliance magazines. He is certified in Quality and Regulatory and holds a Master of Science in Quality Assurance and Regulatory Affairs.
Contents: Introduction; Part I Evolution of Process Design and Management: Why process management is important; Artisan heritage. Part II Five Process Elements: Man: the mind of the process; Machine: the voice of the process; Method: the techniques of process control; Materials: the life-blood of the process; Environment. Part III Effective Pharmaceutical Process Design and Management: Changing the way we think; Cause and effect: getting to the root cause; Corrective action and preventive action: fixing the inevitable oops; Process-driven quality systems; Statistics and decision boundaries: data certainty; Problem-solving tools and techniques; Reducing the risk: the new paradigm; Customers; Process integrated accounting; Appendix; List of references; Index.
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- ID: 9781409427117
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