Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

Editor(s): Joachim Ermer, John H. McB. Miller

Published Online: 5 AUG 2005

Print ISBN: 9783527312559

Online ISBN: 9783527604685

DOI: 10.1002/3527604685

About this Book

Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness.
Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends.
With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

Table of contents

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  1. Part I: Fundamentals of Validation in Pharmaceutical Analysis

    1. Chapter 2

      Performance Parameters, Calculations and Tests (pages 21–194)

      Dr. Joachim Ermer, Dr. Christopher Burgess, Dr. Gerd Kleinschmidt and Dr. John H. McB. Miller

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  2. Part II: Life-Cycle Approach to Analytical Validation

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