Practical Approaches to Method Validation and Essential Instrument Qualification

Practical Approaches to Method Validation and Essential Instrument Qualification

Editor(s): Chung Chow Chan, Herman Lam, Xue Ming Zhang

Published Online: 1 OCT 2012 08:30AM EST

Print ISBN: 9780470121948

Online ISBN: 9780470630716

DOI: 10.1002/9780470630716

About this Book

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.

Table of contents

    1. You have free access to this content
    2. Chapter 1

      Overview of Risk-Based Approach to Phase Appropriate Validation and Instrument Qualification (pages 1–10)

      Chung Chow Chan, Herman Lam, Xue Ming Zhang, Stephan Jansen, Paul Larson, Charles T. Manfredi, William H. Wilson and Wolfgang Winter

    3. Chapter 6

      Cleaning Validation (pages 93–110)

      Xue Ming Zhang, Chung Chow Chan and Anthony Qu

    4. Chapter 10

      Operational Qualification in Practice for Gas Chromatography Instruments (pages 201–230)

      Wolfgang Winter, Stephan Jansen, Paul Larson, Charles T. Manfredi, William H. Wilson and Herman Lam

    5. You have free access to this content

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