Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing

Method validation is therefore an essential component of the measures that a laboratory should implement to allow it to produce reliable analytical data. In some sectors, most notably in the analysis of food, the requirement for methods that have been “fully validated” is prescribed by legislation. ‘Full’ validation for an analytical method is usually taken to comprise an examination of the characteristics of the method in an interlaboratory method performance study (also known as a collaborative study or collaborative trial). Internationally accepted protocols have been established for the ‘full’ validation of a method of analysis by a collaborative trial, most notably the International Harmonised Protocol and the ISO procedure. These protocols/standards require a minimum number of laboratories and test materials to be included in the collaborative trial to validate fully the analytical method.