This book contains both the theory and practice of risk management (RM) and provides the background, tools, and application of risk in pharmaceutical and biologics manufacturing and operations. It includes case studies and specific examples of use of RM for biological and pharmaceutical product manufacture. The book also includes useful references and a bibliography for the reader who wishes to gain additional knowledge in the subject. It aids in assisting both industry and regulatory agencies to implement compliant and effective risk management approaches, and includes case studies to help with understanding.

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