chapter  1
22 Pages

Introduction to Analytical Method Validation

The primary focus of this book is analytical method validation (AMV); however, it is important to have a perspective on where AMV fits into the overall process of validation, in addition to how the process is governed and regulated, before going into too much detail. Therefore, this chapter provides a brief overview of the drug development process; the organization and hierarchy of the main regulatory agency, the Food and Drug Administration (FDA); important contributions of the International Conference on Harmonization (ICH); and pertinent AMV guidelines and their purpose. It also discusses the basic concepts of how AMV fits into the overall validation process, how AMV differs depending on the various phases of the drug development process, and addresses the importance of trained personnel in a regulated environment.