The validation of methods for regulatory purposes in the control of residues.

The topic of validation is diversified. This review outlines the validation strategies which can be found in national, international and supranational regulations, compares them with one another and aims to elaborate on the main principles. European regulations and legislation, Codex alimentarius guidelines, the official methods program of the AOAC, and naturally the relevant ISO standards, particularly the ISO 5725 series, are taken into consideration. The objective of every validation is to demonstrate fitness for purpose. This varies of course in its characteristics for the diverse uses. However, all approaches have in common the objective of harmonisation of food control by using effective and reliable methods. To this end, criteria are determined and validation models developed and made compulsory. ISO 5725 is the central basis for validations for quantitative methods with its validation specifications through method collaborative studies. On the contrary, there are no valid uniform international method specifications for qualitative methods. Collaborative studies are in opposition to single-lab-validations with different sources of error. Whereas laboratory errors are predominant in collaborative studies, the single-lab-validation or in-house validation concentrates particularly on time and processing errors (intermediate precision). In new statistical models for in-house validations, the matrix mismatch error is also considered. The validation models presented here are of a general nature and can be used in principle for all analytical methods. Correct and appropriate statistical modelling is very important.