Guidance Document for Single Laboratory Validation of Quantitative Analytical Methods – Guidance Used in Support of Pre-and-Post-Registration Data Requirements for Plant Protection and Biocidal Products

Method validation is required in order to demonstrate that a particular method of analysis is fit for its intended purpose. Single laboratory validation is the logical conclusion to the method development process and provides assurance that the method has met specific requirements of performance. A single laboratory validation may precede a more rigorous multi-laboratory collaborative validation or method transfer study. This document provides guidance on single laboratory validation of quantitative analytical methods used for the identification and quantification of the active substance and impurities in support of pre-and-post-registration data requirements for plant protection and biocidal products.