AOAC ISPAM Stakeholder Panel Meeting Book (August 26, 2018)

Action Item #1 -C

ƒ Breakdown by Specific Technology

Technology

#1

#2

#3

#4

Total # of Methods Reviewed

5

2

2

3

Total # of Matrices Evaluated

109

6

108

37

Total # Levels of Contamination OOS (DM > 0.5, p-value <0.005, POD - Fail)

327

18

324 112

54 (16.5%)

0 (0.0%)

32 (9.9%)

14 (12.5%)

Contamination Level OOS Low Medium High

6 4 4

17 11 4

0 0 0

25 17 12

Action Item #2

1. Determine Acceptance Criteria for methods regarding: A. Number of acceptable deviations that may occur during the validation of an alternative method Examples 1. Acceptable deviations per claim

2. Broad Approach : 1 deviation per 3 matrices