چگونه یک فرآیند دارویی را اعتبارسنجی کنیم: بخشی از مجموعه تخصص در فناوری فرآیند دارویی

__How to Validate a Pharmaceutical Process__ provides a “how to” approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the __Expertise in Pharmaceutical Process Technology__ __Series,__ this bookillustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why” is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. * Thoroughly referenced and based on the latest research and literature * Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful * Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

How to Validate a Pharmaceutical Process provides a “how to” approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why” is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation.

• Thoroughly referenced and based on the latest research and literature
• Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful
• Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

Content: Front-matter,Copyright,Dedication,Author Biography,Preface,Acknowledgment,About the Expertise in the Pharmaceutical Process Technology SeriesEntitled to full textSection I: Introduction to Process ValidationChapter 1 - Introduction to Process Validation (PV), Pages 3-13 Chapter 2 - A Brief Review of the Regulations*, Pages 15-31 Chapter 3 - The Validation Life Cycle and Change Control, Pages 33-42 Chapter 4 - Getting Started, Pages 45-58 Chapter 5 - Basic Equipment and Utility Qualification1, Pages 59-70 Chapter 6 - Computers and Automated Systems, Pages 71-86 Chapter 7 - Process Development*, Pages 89-102 Chapter 8 - The Process Validation Protocol—PPQ, Pages 103-112 Chapter 9 - Dealing With Deviations, Pages 113-118 Chapter 10 - Stage III—Collection and Evaluating Production Data, Pages 121-130 Chapter 11 - Cleaning and Facility Qualification, Pages 133-140 Terms and Definitions, Pages 141-151 Appendix A - 21 CFR 211, Pages 153-190 Appendix B - Example—Short Change Control Form, Pages 191-192 Appendix C - Additional ICH and FDA Guidelines, Pages 193-194 Index, Pages 195-199 How to Validate a Pharmaceutical Process provides a?how to{u0094} approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the?why{u0094} is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more