Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

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.

1 Introduction and Background Hal Baseman and A. Hamid Mollah 2 Risk Management Tools Mark Walker and Tom Busmann 3 Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration Mike Long 4 Statistical Topics and Analysis In Risk Assessment Mike Long 5 Quality by Design Bruce Davis 6 Process Development and Clinical Manufacturing Karen Ginsbury 7 Points to Consider for Commissioning and Qualification of Manufacturing Facilities and Equipment Hal Baseman and Mike Bogan 8 Quality Risk Management in Process Lifecycle Validation A. Hamid Mollah and Scott Bozzone 9 Aseptic Processing: One James Agalloco and James Akers 10 Aseptic Processing: Two Edward C. Tidswell 11 Pharmaceutical Product Manufacturing Marlene Raschiatore 12 Quality Risk Management in Biopharmaceutical Manufacturing Ruhi Ahmed and Tom Genova 13 Risk Based Change Control Bill Harclerode, Bob Moser, Jorge Ferreira, and Christophe Noualhac Index