Risk Management Applications In Pharmaceutical And Biopharmaceutical Manufacturing Harold Baseman by Harold Baseman, Mike Long, Hamid Mollah 9780470552346, 9781118514399, 0470552344, 1118514394 instant download after payment.
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.
Content:
Chapter 1 Background and Introduction (pages 1–15): Harold S. Baseman and A. Hamid Mollah
Chapter 2 Risk Management Tools (pages 17–47): Mark Walker and Thomas Busmann
Chapter 3 Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration (pages 49–73): Mike Long
Chapter 4 Statistical Topics and Analysis in Risk Assessment (pages 75–88): Mike Long
Chapter 5 Quality by Design (pages 89–100): Bruce S. Davis
Chapter 6 Process Development and Clinical Product Manufacturing (pages 101–127): Karen S. Ginsbury
Chapter 7 Points to Consider for Commissioning and Qualification of Manufacturing Facilities and Equipment (pages 129–177): Harold S. Baseman and Michael Bogan
Chapter 8 Process Lifecycle Validation (pages 179–225): A. Hamid Mollah and Scott Bozzone
Chapter 9 Aseptic Processing: One (pages 227–242): James P. Agalloco and James E. Akers
Chapter 10 Aseptic Processing: Two (pages 243–274): Edward C. Tidswell
Chapter 11 Pharmaceutical Product Manufacturing (pages 275–323): Marlene Raschiatore
Chapter 12 Biopharmaceutical Manufacturing (pages 325–366): Ruhi Ahmed and Thomas Genova
Chapter 13 Risk?Based Change Control (pages 367–385): William Harclerode, Bob Moser, Jorge A. Ferreira and Christophe Noualhac
