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Cover image for Pharmaceutical process design and management
Title:
Pharmaceutical process design and management
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Publication Information:
Farnham, Surrey : Gower, c2011.
Physical Description:
x, 268 p. ; 25 cm.
ISBN:
9781409427117

9781409427124
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30000010306668 HD9665.5 M366 2012 Open Access Book Book
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Summary

Summary

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.


Author Notes

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.


Table of 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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