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Practical Approaches to Method Validation and Essential Instrument Qualification

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  • Author(s)Chung Chow Chan / Herman Lam / Xue-Ming Zhang
  • Edition1
  • Published11th August 2010
  • PublisherJohn Wiley & Sons Inc (US)
  • ISBN9780470121948

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

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