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Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

ISBN: 978-3-527-31255-9
418 pages
March 2005
Method Validation in Pharmaceutical Analysis: A Guide to Best Practice (3527312552) cover image
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.
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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
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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.
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"The book contains a number of case studies and this brings the subject to life...This book would be a useful addition to the bookshelf of a pharmaceutical analysis laboratory."
BTS Newsletter, Summer 2005

"This book fills a gap for a comprehensive, comprehensible and illustrative guidebook and reference on current method validation in pharmaceutical analysis. I would thoroughly recommend purchase of this book which I would anticipate will become highly cited over the coming years."

"...a well-written textbook with well-organized chapters...extensively referenced from world-renowned experts in the field."
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