Overview

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.

Full Product Details

Author:   Joachim Ermer (sanofi-aventis, Frankfurt, Germany) ,  John H. McB. Miller (European Directorate for the Quality of Medicines (EDQM), Strasbourg, France)
Publisher:   Wiley-VCH Verlag GmbH
Imprint:   Wiley-VCH Verlag GmbH
Dimensions:   Width: 17.60cm , Height: 2.70cm , Length: 24.30cm
Weight:   0.932kg
ISBN:  

9783527312559

ISBN 10:   3527312552
Pages:   418
Publication Date:   15 February 2005
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Out of Print
Availability:   In Print  
Limited stock is available. It will be ordered for you and shipped pending supplier's limited stock.

Table of Contents

Preface.List of Contributors.Part I: Fundamentals of Validation in Pharmaceutical Analysis.1 Analytical Validation within the Pharmaceutical Environment (Joachim Ermer).2 Performance Parameters, Calculations and Tests.3 Case Study: Validation of an HPLC-Method for Identity, Assay, and Related Impurities (Gerd Kleinschmidt).Part II: Life-cycle Approach to Analytical Validation.4 Qualification of Analytical Equipment (David Rudd).5 Validation During Drug Product Development - Considerations as a Function of the Stage of Drug Development (Martin Bloch).6 Acceptance Criteria and Analytical Variability (Hermann Watzig).7 Transfer of Analytical Procedures (Mark Broughton and Joachim Ermer (Section 7.3)).8 Validation of Pharmacopoeial Methods (John H. McB. Miller).9 Analytical Procedures in a Quality Control Environment (Raymond A. Cox).10 Aberrant or Atypical Results (Christopher Burgess).11 Future Trends in Analytical Method Validation (David Rudd).Index.

Reviews

"""...a well-written textbook with well-organized chapters...extensively referenced from world-renowned experts in the field."" (E-STREAMS, September 2005) "" ... the book contains a number of case studies and this brings the subject to life."" (BTS Newsletter, Summer 2005)"

...a well-written textbook with well-organized chapters...extensively referenced from world-renowned experts in the field. (E-STREAMS, September 2005) ... the book contains a number of case studies and this brings the subject to life. (BTS Newsletter, Summer 2005)

Author Information

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.

Tab Content 6

Author Website:  

Countries Available

All regions