Method Validation in Pharmaceutical Analysis

A Guide to Best Practice

Ermer, Joachim / Miller, John H. McB. (Herausgeber)

1. Auflage Januar 2005
XIV, 404 Seiten, Hardcover
138 Abbildungen (9 Farbabbildungen)
99 Tabellen
Praktikerbuch

ISBN: 978-3-527-31255-9

Wiley-VCH, Weinheim

Kurzbeschreibung

With their first-hand knowledge of both the industry and regulating bodies, the authors interpret in detail existing regulations, while discussing the appropriate calculations, parameters and tests. The book thus allows readers to comply with the regulations as well as with the industry demands for speed and low costs.
A practical reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

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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."
Pharmazie in unserer Zeit

Joachim Ermer is Director of Analytical Processes and Technology in Quality Operations, Global Analytical Development of Aventis. He is responsible for supporting and advising the Quality Control sites in analytical aspects, including training. Before joining Hoechst in Frankfurt as Head of Laboratory in Pharma Quality Control Development Products in 1991, he obtained his PhD in biochemistry from University of Halle, Germany in 1988 and worked as research scientist and post-doc fellow at the Universities of Halle and Cambridge, UK. He has a broad experience in analytical activities in pharmaceutical development and quality control, such as method development, specification design, regulatory documentation, etc. His special interests are validation and related topics to achieve robust and reliable analytical procedures.

J. Ermer, sanofi-aventis, Frankfurt, Germany; J. H. M. Miller, European Directorate for the Quality of Medicines (EDQM), Strasbourg, France