Establishing juristically valid performance of methods

It is generally recognized and accepted that analytical methods must be suitable for the intended use. Furthermore, EU Directives 85/591/EEC, 89/397/EEC and 93/99/ EEC state that analytical procedures for compliance testing with food laws are to be carried out on the basis of validated methods. Method validation is known as the process used to confirm that a procedure is fit for a particular analytical purpose. This process, an essential part of analytical quality assurance, can be described as the set of tests used to establish and document performance characteristics of a method. The performance characteristics of a method are experimentally derived values for the fundamental parameters of importance in assessing the suitability of the method (Horwitz 1988, 1995 Thompson and Wood 1993, 1995 Eurachem 1996 FAO 1998 US EPA 1995 US FDA 1993a). These parameters include  

Applicability Includes the matrix, analyte and species being measured, con- 

Selectivity The ability to discriminate between the target analyte and 

Calibration The calibration curve is a graphic representation of the detec- 

Accuracy The closeness of agreement between a test result and the 

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