AOAC SPIFAN Stakeholder Program Meeting Book (March 17, 2021)

2. General

X Added a reference to SLV protocol: Gill et al (2015), Journal of AOAC International, 98, 112–115. X Added System Suitability Criteria to indicate method/system performance is acceptable X Added a paragraph that suggests to evaluate robustness/ruggedness of an analytical method. With such test one measures the capacity of a method result to remain unaffected by small but deliberate variations in method parameters. Several references to evaluate robustness/ruggedness of the method are suggested. X Added a sentence that states that units of measure for reported values and figures of merit must be consistent with those in the associated SMPR

Gill, B.D., Indyk, H.E., Blake, C.J., Konings, E.J., Jacobs, W.A., & Sullivan, D.M. (2015). Evaluation Protocol for Review of Method Validation Data by the AOAC Stakeholder Panel on Infant Formula and Adult Nutritionals Expert Review Panel. Journal of AOAC International, 98, 112–115.

3. Materials

X Whole section added to clarify which samples need to be included in the SLV X Use CRM when available (for each type of matrix if multiple matrices are defined in the SMPR) X No CRM available? Own reference material can be used, but the concentration of the analyte should be assessed by appropriate, highly specific techniques. E.g. statistically equivalent results from two or more different techniques from two independent analyses preferably by different labs. The assessment protocols and results should be included in the SLV report. X Reference standard need a CoA. For non-commercial reference standards its origin needs to be identified, purity and/or analyte concentration demonstrated and the means with which these were determined. X Number of matrices: X Multiple defined: at least 1 per matrix type (covering range of expected concentrations) X 6LQJOH PDWUL[ • VRXUFHV SUHIHUDEO\ GLIIHUHQW DWWULEXWHV H J PDWXULW\ variety, age)