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Development and Validation of Analytical Methods
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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. The scope of this book was expanded considerably from our original intent of considering only the validation of analytical methods. As we began the process of planning the layout of the book, it became clear that factors such as method development, data acquisition systems and regulatory considerations were all closely interrelated with validation and that a text on validation would not be complete without rather detailed discussions of all these components. 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 testing, robotics and automated systems, biotechnology related products, materials presented in biological matrices, cleaning procedures, and data acquisition systems. 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 an analytical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH, 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. The initial concepts for this book were developed while one of us (CMR) was on sabbatical leave from the University of Kansas at Hoechst Marion Roussel in Kansas City. We wish to express our gratitude to Dr. Michael Baltezor (Senior Director, Analytical Chemistry, Hoechst Marion Roussel) for providing us with access to resources in his department and for the opportunity to collaborate on this book. Christopher M. Riley Thomas W. Rosanske January 2, 1996 |
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