Momentum Press is proud to present the fourth volume of the WBF series, ISA-88 and ISA-95 in the Life Science Industries. Written by experts from companies such as Pfizer, Merck, Genentech, and Amgen, the book explains the use of these standards to reduce design, implementation and training problems unique to these industries.
The life science industries make products that directly affect the health of people. They are regulated by government agencies to assure that products are safe and effective, and that manufacturing processes will not vary in ways that affect product quality. Many of the chapters in this book address that very same verification and validation of products and processes. Other chapters describe ways to shorten new product development time—from identification of a need for a new process to actual production of products. In addition, case studies and implementation experiences further describe ways to get the most from the ISA standards in the book’s title.
You will find incredibly valuable information in chapters such as:
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ISA-88 Provides a Framework for a Pharmaceutical Process Module Library
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ISA-88 Design and Implementation Case Study for a Complex Bulk Pharmaceutical Batch Process
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Batch On-line Analytics : A Solution Beyond Six Sigma
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The Road to Full MES Integration : Practical Experience from the Pharmaceutical Industry
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Risk-based Engineering Assessment and Qualification : A Case Study
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Multiple Products in a Monoclonal Antibody ISA-88.01 Batch Plant
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Using General Recipes for Standardized Multiple Plant Manufacturing Science
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Manufacturing Science Model Extensions to Address Quality by Design and Risk Assessments
List of Figures
List of Tables
WBF Foreword
Foreword by Walt Boyes
Preface
Chapter 1 : ISA-88 Provides a Framework for a Pharmaceutical Process Module Library
Chapter 2 : ISA-88 Design and Implementation Case Study fora Complex Bulk Pharmaceutical Batch Process
Chapter 3 : Managing Complex Equipment Status in a GMP Environment
Chapter 4 : Impact of Batch Software Upgrades on Validated Batch Applications
Chapter 5 : Is It Possible to Build a Pharmaceutical Plant in 18 Months or Less Using ISA-88?
Chapter 6 : Batch On-line Analytics : A Solution Beyond Six Sigma
Chapter 7 : Implementing ISA-88 across Life Science Development Operations
Chapter 8 : Process De%uFB01nition Management : Using ISA-88 and BatchMLas a Basis for Process De%uFB01nitions and Recipe Normalization
Chapter 9 : ISA-88 Design and Implementation Case Study for a Pharmaceutical Batch Process
Chapter 10 : Product Life-cycle Stages Linked Using ISA-88 and ISA-95
Chapter 11 : Jazz Up Your Batch Projects
Chapter 12 : The Challenge of Integrating Multiple Batch Systems to Global Business Systems
Chapter 13 : The Road to Full MES Integration : Practical Experience from the Pharmaceutical Industry
Chapter 14 : MES Roll-out in a Regulated Environment : Reducing the Costs of Validation Based on Risk Assessment
Chapter 15 : Fast and Ef%uFB01cient Con%uFB01guration and Integration of Automation Solutions from a Global Perspective : A Practical Approach
Chapter 16 : Risk-based Engineering Assessment and Quali%uFB01cation : A Case Study
Chapter 17 : Lean Computer Validation through a Risk-based Approach : A Case Study
Chapter 18 : Multiple Products in a Monoclonal Antibody ISA-88.01 Batch Plant
Chapter 19 : Considerations for Managing Global Recipe Development
Chapter 20 : General Recipes as Contracts with Manufacturing
Chapter 21 : Using General Recipes for Standardized Multiple Plant Manufacturing Science
Chapter 22 : Manufacturing Science Model Extensions to Address Lean Manufacturing and Supply Chain Optimization
Chapter 23 : Manufacturing Science Model Extensions toAddress Product and Process Sustainability
Chapter 24 : Manufacturing Science Model Extensions toAddress Quality by Design and Risk Assessments
Chapter 25 : Batch Release and Material Use Reporting : A Case Study
Index
