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Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

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

ISBN: 978-3-527-60447-0

Mar 2006

418 pages



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.
Analytical Validation within the Pharmaceutical Environment
Performance Parameters, Calculations and Tests
Case Study: Validation of an HPLC-Method for Identity, Assay, and Related Impurities
Qualification of Analytical Equipment
Validation During Drug Product Development -
Considerations as a Function of the Stage of Drug Development
Acceptance Criteria and Analytical Variability
Transfer of Analytical Procedures
Validation of Pharmacopeial Methods
Analytical Procedures in a Quality Control Environment
Aberrant or Atypical Results
Future Trends in Analytical Method Validation
"Das Werk ist ein Muss für alle Kolleginnen und Kollegen, die sich in ihrer praktischen Arbeit mit der Validierung pharmazeutisch-analytischer Verfahren beschäftigen - im besten Sinne "A Guide to Best Practice"; es ist auch ein fundamentales Nachschlagewerk für das Thema insgesamt und damit auch wertvoll im regulatorischen und akademischen Umfeld."
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