Institute for Medical Research and Occupational Health
Abstract
Method validation is a key element in the establishment of reference methods and in the assessment of a laboratory’s competence in producing reliable analytical data. Hence, the scope of the term »method validation« is wide, especially if one bears in mind the role of Quality Assurance/Quality Control (QA/QC). The paper puts validation in the context of the process generating chemical information, introduces basic performance parameters included in the validation processes, and evaluates current approaches to the problem.
Two cases are presented in more detail: the development of European standard for chlorophenols and its validation by a full scale collaborative trial and the intralaboratory validation of a method for ethylenethiourea (ETU) by using alternative analytical techniques.Vrednovanje metoda ključni je postupak u utvrđivanju referentnih metoda i procjeni kompetencije laboratorija da proizvodi pouzdane rezultate analiza. Stoga je značenje širine okvira ovog termina posebice važno jer valja imati na umu i ulogu osiguranja kakvoće i kontrole kakvoće.
Autori stavljaju postupak vrednovanja metoda u kontekst proizvodnje kemijskoanalitičkih podataka, upoznaju čitatelja s osnovnim parametrima pri ocjeni uspješnosti te ocjenjuju trenutne pristupe ovom problemu.
U dva je primjera posebna pozornost posvećena razvoju europske norme za klorofenole i njezinoj ocjeni opsežnim pokusom te unutarlaboratorijskom potvrdom metode za određivanje etilentioureje rabeći alternativne analitičke tehnike
