The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations.

The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.

Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples.

Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contai


For undergraduate pharmacy students and chemistry students; postgraduate students and faculty in analytical chemistry, pharmaceutical chemistry, pharmaceutical analysis, pharmaceutics and medicinal chemistry; analytical scientists in government, pharmaceutical industry and biotechnology industry and regulatory agencies.

Table of Contents

Section headings and papers: List of Contributors. Introduction. Basic Concepts. Assay validation and inter-laboratory transfer (E. McGonigle). Statistical parameters and analytical figures of merit (C.M. Riley). Regulatory Considerations. Overview of worldwide regulations (I.E. Davidson). Issues related to United States v. Barr Laboratories Inc. (C.L. Burgess). Judge Wolin's interpretations of current good manufacturing practice issues contained in the court's ruling in the United States v. Barr Laboratories (R.J. Davis). Specific Methods and Applications. Bulk drug substances and finished products (P.K. Hovsepian). Dissolution studies (T.W. Rosanske, C.K. Brown). Robotics and automated workstations (J.J. Tomlinson). Biotechnology products (G.S. Srivatsa). Biological samples (K.A. Selinger). Analytical methods for cleaning procedures (T.M. Rossi, R.R. Ryall). Computer systems and computer-aided validation (J.G. Liscouski). Index.

40 line drawings.


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© 1996
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About the editors

Christopher M. Riley

President of Riley and Rabel Consulting Services. Former Vice President of Analytical R&D at DuPont Pharmaceutical Company, and Vice President of ChemPharm at ALZA (a division of Johnson and Johnson) as well as a member of the ICH Expert Working Group on Impurities.

Affiliations and Expertise

President of Riley and Rabel Consulting Services, Maryville, MO, USA

Thomas W. Rosanske

Director of Business Development at Acceleration Laboratory Services, Incorporated. He has previously held scientific and senior management positions at The Upjohn Company, Marion Laboratories, Marion Merrell Dow, Hoechst Marion Roussel, Quintiles, Eli Lilly, Beckloff Associates, and PPD. He currently serves on a Small Molecule USP Expert Committee.

Affiliations and Expertise

Director of Business Development at Acceleration Laboratory Services, Inc., Lee's Summit, MO, USA


@from:G.P. Carr @qu:...this book contains a great deal of material on applications of analytical methods which should be very valuable to analytical chemists employed within the pharmaceutical industry. @source:Analyst