Practical Approaches to Method Validation and Essential Instrument Qualification High quality books
Practical Approaches to Method Validation and Essential Instrument Qualification
By:Chung Chow Chan,Herman Lam,Xue-Ming Zhang
Published on 2011-03-01 by John Wiley & Sons
Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.
This Book was ranked at 41 by Google Books for keyword instrument.
Book ID of Practical Approaches to Method Validation and Essential Instrument Qualification's Books is M63bcATAE1MC, Book which was written byChung Chow Chan,Herman Lam,Xue-Ming Zhanghave ETAG "LnG448kRIEU"
Book which was published by John Wiley & Sons since 2011-03-01 have ISBNs, ISBN 13 Code is 9781118060315 and ISBN 10 Code is 1118060318
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