Pharmaceutical Process Design and Management

By: Kate McCormick, D. Wylie McVay Jr

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Hardcover | 28 July 2012 | Edition Number 1

At a Glance

Hardcover
290 Pages

Edition Type
New edition

Dimensions(cm)
25.4 x 17.78 x 1.75

Hardcover

$532.75

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The pharmaceutical industry is in operational turmoil. There has been much talk about the 'new paradigm' and 'risk-based scientific approaches' to pharmaceutical manufacturing. Financial results directly attributable to Quality by Design are difficult to quantify and are often limited to estimates of opportunity costs. There is little practical guidance to achieve the desired state - first order quality systems. This book sets out to fill that gap by taking a pragmatic, stepwise approach to the design and implementation of processes and process management.Using their considerable knowledge and experience of pharmaceutical manufacturing, the authors take the reader through the various elements involved in a process: man, machine, materials, method and environment. They discuss quality control and quality 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. This book shows the reader how to do just that.The package works on several levels. On its own, the book is Process Management 101. With the associated presentations and lecture notes, it is a resource for courses related to pharmaceutical manufacturing, such as pharmacy, pharmaceutical engineering or QP training. Finally, with the optional add-on of the process costing program, it becomes a practical manual for setting up a simple managerial cost measurement system, which effectively integrates with the financial reporting system.

Industry Reviews

'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

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