By
C.M. Riley, DuPont Merck Pharmaceutical Company, Experimental Station, PO Box 80353, Wilmington, DE 19008, USA
T.W. Rosanske, Hoechst Marion Roussel, Inc., PO Box 9627, Park A-025, Kansas City, MO 64134, USA
Description
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 contains specific chapters dedicated to bulk drug substances and finished products,
dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning
procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development
and related validation considerations for each topic.
This book is not intended to be a practical description of the analytical validation
process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program.
Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of
assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless,
this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical
industry in an attempt to bring some consistency to analytical method development and validation.
Included in series
Progress in Pharmaceutical and Biomedical Analysis
Audience:
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.
