2nd Edition - April 1, 2022
  • Authors: Kate McCormick, Janet Sanders
  • Paperback ISBN: 9780323908153

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Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. This book provides the background theory, applied descriptions of the guidelines and concepts, plus questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts.  In this book the authors share their combined 60+ years of extensive practical experience in the industry and in process improvement combined with detailed understanding of the needs of the industry and education system. This book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management.This book is fully revised, updated, and expanded with new content in areas such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools.

Key Features

  • Fully revised, updated and 25% expanded new edition
  • Features new topics such as QbD, Lean, Six Sigma, Basic data analysis, CAPA tools, and Pharma 4.0
  • Includes end-of-chapter summaries, questions and/or problems
  • Presents real-life case studies from industry
  • Provides detailed steps and examples for applying the guidelines and quality tools


Pharmaceutical Manufacturing companies: managerial and supervisory levels; QPs; Bioprocess companies: managerial and supervisory levels; QPs Pharmaceutical Certification Organizations; Industry associations; Technical and academic libraries; Industry training bodies; FDA, EMA, PMDA, WHO, and other governmental agencies

Table of Contents

  • 1. Product Life Cycle
    2. Elements of Quality Management
    3. Quality Systems
    4. The Management of Quality
    5. Good Manufacturing Practice
    6. Validation
    7. Good Distribution Practice
    8. Technology Transfer
    9. Inspection and Auditing
    10. Calibration
    11. Pharmaceutical Microbiology
    12. Water for Pharmaceutical Use
    13. Quality Improvement Programmes
    14. Corrective and Preventative Action Using Quality Tools and Techniques

Product details

  • No. of pages: 362
  • Language: English
  • Copyright: © Butterworth-Heinemann 2022
  • Published: April 1, 2022
  • Imprint: Butterworth-Heinemann
  • Paperback ISBN: 9780323908153

About the Authors

Kate McCormick

Dr. Kate McCormick is a pharmaceutical manufacturing consultant and trainer who has worked extensively with both regulators and companies in more than 50 countries. She is the author of a number of textbooks, and she was an editor of GMP Review and International Education Advisor for ISPE. Dr. McCormick has a degree in biochemistry, a doctorate in microbiology, and is also a Master of Business Administration.

Affiliations and Expertise

Consultant, Heathside Information Services Limited, Kent, UK

Janet Sanders

Janet H. Sanders is an Associate Professor in the Department of Technology Systems at East Carolina University where her research focus includes quality, statistics, Lean Six Sigma, and process improvement methodologies. She has a BS in Ceramic Engineering, MS in Industrial Management, and a PhD in Industrial Engineering, and 30+ years of process improvement experience in various manufacturing, service, and healthcare industries.

Affiliations and Expertise

Associate Professor, East Carolina University, USA