AOAC GFA Stakeholder Program Meeting Book (August 27, 2023)

PAGE FIVE – METHOD DEVELOPER VALIDATION - SCOPE

4.1 Scope A Single Laboratory Validation (SLV) study (also referred to as a Method Developer Study), is intended to evaluate the performance of a candidate method in the following areas: (1) calibration fit, (2) selectivity, (3) precision (repeatability and intermediate precision), (4) sensitivity, (5) recovery, and (6) robustness. These studies are generally conducted within a method developer laboratory.

Would like to see statement similar to the Gluten Qualitative document “Gluten has multiple potential sources… and perform validation for each claimed gluten source.”

QUALITATIVE DOCUMENT READS: 4.1.1 Scope

The method developer validation study is intended to determine the performance of a method under the controlled conditions of a laboratory. The study is designed to evaluate performance parameters including cross-reactivity, interference, POD at regulatory level(s), robustness, between-device variation, lot-to-lot variability and product stability. Gluten has multiple potential sources – wheat, rye, barley, oats and their hybrids and crossbreeds – and multiple regulatory levels. Developers must determine which of these sources and levels their method is intended to detect, and perform interference and POD studies for each claimed gluten source.