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.…mehr
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.
Inhaltsangabe
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
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
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