ABSTRACT
Validation is necessary to demonstrate the performance and reliability of a method and to determine the confidence that can be placed in the results it generates. Method validation in most areas of analytical science is governed by regulations such as those from t.he Federal Drug Administration (FDA) in the case of pharmaceutical analysis and the Environmental Protection Agency (EPA) in the analysis of agrochemicals and pesticide residues. The pharmaceutical industry regulations have tended to be the most stringent and the recently published Washington Conference Report (Shah et al., 1992) is probably the most up to date view of analytical method validation. It is likely that this report will form the basis of future FDA formal guidelines for analytical method validation within the pharmaceutical industry and it has been adopted as the basis for the discussions presented here.
