Pharmaceutical Process Design and Management

ISBN-13: 9781138255500 / Angielski / Miękka / 2016 / 288 str.

Kate McCormick; D. Wylie McVay Jr

Opis

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.

Recenzje

'This book is comprehensive, practical and brings new thinking to the manufacture of pharmaceutical products. The authors demonstrate a wealth of experience and use numerous examples from real life. They present innovative ideas in context with current thinking, the regulatory environment and the industry's history. It is a valuable resource for anyone seeking information on modern approaches to pharmaceutical production.' Bruce Davis (Global Consulting), Principal '...a valuable resource for those seeking information on the modern approach to pharmaceutical production. If your aim is to employ a scientific and risk-based approach to the manufacturing process while maximising profit and ensuring customer satisfaction, then Pharmaceutical Process Design and Management should form part of your reference material.' Quality World

Spis treści

 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.

O autorze

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.