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. This book assists both industry as well as regulatory agencies to implement compliant and effective risk management approach, 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.
1 Introduction and BackgroundHal Baseman and A. Hamid Mollah
2 Risk Management Tools
Mark Walker and Tom Busmann
3 Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration
4 Statistical Topics and Analysis In Risk Assessment
5 Quality by Design
6 Process Development and Clinical Manufacturing
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
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