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.

Sets forth tested and proven risk management practices indrug manufacturingRisk management is essential for safe and efficientpharmaceutical and biopharmaceutical manufacturing, control, anddistribution. With this book as their guide, readers involved inall facets of drug manufacturing have a single, expertly writtenand organized resource to guide them through all facets of riskmanagement and analysis. It sets forth a solid foundation in riskmanagement concepts and then explains how these concepts areapplied to drug manufacturing.Risk Management Applications in Pharmaceutical andBiopharmaceutical Manufacturing features contributions fromleading international experts in risk management and drugmanufacturing. These contributions reflect the latest researchpractices, and industry standards as well as the authors' firsthandexperience. Readers can turn to the book for:* Basic foundation of risk management principles, practices, andapplications* Tested and proven tools and methods for managing risk inpharmaceutical and biopharmaceutical product manufacturingprocesses* Recent FDA guidelines, EU regulations, and internationalstandards governing the application of risk management to drugmanufacturing* Case studies and detailed examples demonstrating the use andresults of applying risk management principles to drug productmanufacturing* Bibliography and extensive references leading to the literatureand helpful resources in the fieldWith its unique focus on the application of risk management tobiopharmaceutical and pharmaceutical manufacturing, this book is anessential resource for pharmaceutical and process engineers as wellas safety and compliance professionals involved in drugmanufacturing.

Preface viiContributors xiAbout the Authors xiii1 Background and Introduction 1Harold S. Baseman and A. Hamid Mollah2 Risk Management Tools 17Mark Walker and Thomas Busmann3 Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration 49Mike Long4 Statistical Topics and Analysis in Risk Assessment 75Mike Long5 Quality by Design 89Bruce S. Davis6 Process Development and Clinical Product Manufacturing 101Karen S. Ginsbury7 Points to Consider for Commissioning and Qualification of Manufacturing Facilities and Equipment 129Harold S. Baseman and Michael Bogan8 Process Lifecycle Validation 179A. Hamid Mollah and Scott Bozzone9 Aseptic Processing: One 227James P. Agalloco and James E. Akers10 Aseptic Processing: Two 243Edward C. Tidswell11 Pharmaceutical Product Manufacturing 275Marlene Raschiatore12 Biopharmaceutical Manufacturing 325Ruhi Ahmed and Thomas Genova13 Risk-Based Change Control 367William Harclerode, Bob Moser, Jorge A. Ferreira, and Christophe NoualhacIndex 387