Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing
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More About This Title Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing


Sets forth tested and proven risk management practices in drug manufacturing

Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing.

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for:

  • Basic foundation of risk management principles, practices, and applications
  • Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes
  • Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing
  • Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing
  • Bibliography and extensive references leading to the literature and helpful resources in the field

With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.


A. HAMID MOLLAH, PhD, is the Head of Quality Engineering and Validation at XOMA. He has also held positions at Genentech and Baxter. He is a RAPS Certified Regulatory Affairs Professional and ASQ Certified Quality Engineer.

Dr. MIKE LONG, has two decades of experience leading product, process development, and validation efforts on a wide range of pharmaceutical, medical device, and combination products. He is a frequent speaker and writer on topics such as risk management, quality systems, quality by design, and process validation.

HAROLD S. BASEMAN, MBA, Principal and Chief Operating Officer, ValSource LLC, has more than thirty years of experience in pharmaceutical operations, validation, and regulatory compliance. He has held positions in executive management and technical operations at several manufacturing and consulting firms.


Preface vii

Contributors xi

About the Authors xiii

1 Background and Introduction 1
Harold S. Baseman and A. Hamid Mollah

2 Risk Management Tools 17
Mark Walker and Thomas Busmann

3 Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration 49
Mike Long

4 Statistical Topics and Analysis in Risk Assessment 75
Mike Long

5 Quality by Design 89
Bruce S. Davis

6 Process Development and Clinical Product Manufacturing 101
Karen S. Ginsbury

7 Points to Consider for Commissioning and Qualification of Manufacturing Facilities and Equipment 129
Harold S. Baseman and Michael Bogan

8 Process Lifecycle Validation 179
A. Hamid Mollah and Scott Bozzone

9 Aseptic Processing: One 227
James P. Agalloco and James E. Akers

10 Aseptic Processing: Two 243
Edward C. Tidswell

11 Pharmaceutical Product Manufacturing 275
Marlene Raschiatore

12 Biopharmaceutical Manufacturing 325
Ruhi Ahmed and Thomas Genova

13 Risk-Based Change Control 367
William Harclerode, Bob Moser, Jorge A. Ferreira, and Christophe Noualhac

Index 387