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.

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