Practical Approaches to Method Validation and Essential Instrument Qualification PDF (Adobe DRM) download by Chung Chow Chan

Practical Approaches to Method Validation and Essential Instrument Qualification

Wiley
Publication date: August 2010
ISBN: 9780470630709
Digital Book format: PDF (Adobe DRM)

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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.

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Practical Approaches to Method Validation and Essential Instrument Qualification PDF (Adobe DRM) download by Chung Chow Chan
Wiley, August 2010
ISBN: 9780470630709
EAN:  9780470630709
PDF (Adobe DRM)
List Price: $94.99 eBook price: $91.99
Practical Approaches to Method Validation and Essential Instrument Qualification ePub (Adobe DRM) download by Chung Chow Chan
Wiley, March 2011
ISBN: 9781118060315
EAN:  9781118060315
ePub (Adobe DRM)
eBook price: $91.99