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

Test Material Preparation

When can test materials be prepared by the method developer vs. and independent entity? • 5.1.1 Method developers may prepare study test materials in house for the single laboratory validation (method developer study), but all samples and test portions must be blind-coded and randomized. Analysis conducted by the method developer must be performed by an independent analyst without prior knowledge of the test materials undergoing analysis in a given sample set. • 5.1.2. Ideally, all test materials for the independent laboratory and collaborative study should be prepared by an external entity independent from the method developer. At least one incurred test material for the independent laboratory and collaborative study must be prepared by an external entity independent from the method developer. In situations where an independent entity is unavailable to prepare all of the test materials for the independent laboratory and collaborative study, or their use is impractical for all test materials, method developers may produce and distribute test materials as long as detailed information is provided on procedures used to prevent bias (preparation, coding, etc.), and justification is provided for failing to use an independent entity to prepare all of the test materials.