Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics / Edition 1

by Brian K. Nunnally, John S. McConnell

Overview

The pharmaceutical industry is under increasing pressure to do more with less. Drug discovery, development, and clinical trial costs remain high and are subject to rampant inflation. Ever greater regulatory compliance forces manufacturing costs to rise despite social demands for more affordable health care. Traditional methodologies are failing and the industry needs to find new and innovative approaches for everything it does.

Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics is the first book to focus on the building blocks of understanding and reducing variation using the Six Sigma method as applied specifically to the pharmaceutical industry. It introduces the fundamentals of Six Sigma, examines control chart theory and practice, and explains the concept of variation management and reduction. Describing the approaches and techniques responsible for their own significant success, the authors provide more than just a set of tools, but the basis of a complete operating philosophy. Allowing other references to cover the structural elements of Six Sigma, this book focuses on core concepts and their implementation to improve the existing products and processes in the pharmaceutical industry. The first half of the book uses simple models and descriptions of practical experiments to lay out a conceptual framework for understanding variation, while the second half introduces control chart theory and practice. Using case studies and statistics, the book illustrates the concepts and explains their application to actual workplace improvements.

Designed primarily for the pharmaceutical industry, Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics provides the fundamentals of variation management and reduction in sufficient detail to assist in transforming established methodologies into new and efficient techniques.

Product Details

ISBN-13:	9781420054392
Publisher:	Taylor & Francis
Publication date:	06/13/2007
Pages:	220
Product dimensions:	6.12(w) x 9.19(h) x (d)

About the Author

John S. McConnell, Brian K. Nunnally

Table of Contents

The Enormous Initial Mistake,  The Origins of Six Sigma, Evolution,  Revolution,  Paradox, Action and Reaction, Close Enough; … Or On Target?,  Make More…Faster, Case Studies,  The Camera Always Lies, Keeping It Simple, Why Use Control Charts?,  Average and Range Control Charts,  Origins and Theory,  Charts for Individuals,  Practical Considerations, Improving Laboratories, Beyond Compliance, Appendices

Editorial Reviews

Reviewer: Rahmat M. Talukder, PhD, RPh (The University of Texas at Tyler)
Description: This book offers a conceptual basis of the six sigma approach for quality initiatives and business strategies in the pharmaceutical industry. A few case studies and examples are presented to help readers understand the topic.
Purpose: The intent is to provide a basic understanding of the six sigma approach in the pharmaceutical industry to reduce variation in quality. If this approach is adopted, it is expected that production costs will be reduced without compromising quality, an important goal as the pharmaceutical industry is encountering pressure to keep prices down. The book meets the expectations to some degree.
Audience: The book is written for industry executives or decision-making individuals. At least in part, it provides some insights into the quality initiatives based on statistical principles.
Features: The authors begin with an account of the origin of six sigma in other industries. Then they discuss how the same principles have been adopted by the pharmaceutical industry for quality/performance improvement. The authors use a number of examples and case studies, which are helpful in understanding the issues. A brief discussion of the basic structural elements of six sigma and methods of calculating the sigma level would make this book more user friendly.
Assessment: This will be helpful for decision-making individuals in the pharmaceutical industry. This is a timely topic. Cost containment without sacrificing quality is one of the primary goals of any industry and the six sigma approach has been proven to help in this context. Thus, this book will help some in the industry achieve some of their goals.

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