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基本説明
The book shows how to deploy a science and risk-based approach to pharmaceutical manufacturing. It presents the various elements comprising a process (man, machine, materials, method and environment) and looks at quality control, quality assurance, and tools for quality improvements.
Full Description
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.
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.
