Experience in developing generic guidelines for method validation applicable in the areas of animal health, plant health, and food safety

Michel Laurentie (1)

1 Laboratoire de Fougères - ANSES

Experience in developing generic guidelines for method validation applicable in the areas of animal health, plant health, and food safety Abstract A generic guideline for method validation was developed from all laboratories at the French agency for food, environmental and occupational health and safety (ANSES). This guideline takes into account the specificity of the various subject areas, such as animal health, plant health, or food safety. Furthermore it was developed for both qualitative and quantitative methods. A life cycle for analytical methods was also introduced. The process of validation was described according to the principle that the first step is to determine method performance using standard characteristics (trueness, precision, LOQ, sensitivity, and specificity) for qualitative or quantitative methods, and the second step is to compare the studied characteristics with the validation criteria defined in the tender specifications. This process concludes the validation of the analytical method. Estimating the uncertainty of results was also taken into account.

Keywords: method; validation; animal health; plant health; food safety

Keywords: méthode de valiation; santé animale; santé des plantes; sécurité alimentaire

Domains: Statistics [math.ST]; Animal biology

Michel Laurentie. Experience in developing generic guidelines for method validation applicable in the areas of animal health, plant health, and food safety. EuroReference - Les Cahiers de la Référence, 2016, 1, pp.42-47. ⟨anses-01346591⟩