Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Sets forth tested and proven risk management practices indrug manufacturing

Risk 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 written,and 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 research,practices, 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 field

With 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 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

A. HAMID MOLLAH, PhD, is the Head of Quality Engineeringand Validation at XOMA. He has also held positions at Genentech andBaxter. He is a RAPS Certified Regulatory Affairs Professional andASQ Certified Quality Engineer.

Dr. MIKE LONG, has two decades of experience leadingproduct, process development, and validation efforts on a widerange of pharmaceutical, medical device, and combination products.He is a frequent speaker and writer on topics such as riskmanagement, quality systems, quality by design, and processvalidation.

HAROLD S. BASEMAN, MBA, Principal and Chief OperatingOfficer, ValSource LLC, has more than thirty years of experience inpharmaceutical operations, validation, and regulatory compliance.He has held positions in executive management and technicaloperations at several manufacturing and consulting firms.