Microbiology-PTM-OMA_Modules_1-5

Harmonized Studies:  Qualitative cont’d

Type of Analysis

AOAC RI PTM Validation

AOAC OMA Validation ISO 16140‐2 Validation

Product  Consistency/ Stability

3 Lots (Beg, Middle, End) 10 Low/Fractional + 10 Noninoculated

NA

NA

3 Modified Method Parameters ‐ 10 Low/Fractional + 10 Noninoculated Use of Factorial Study Design

Robustness

NA

NA

3 Instruments ‐ 10 Low/Fractional + 10 Noninoculated

Instrument  Variation

NA

NA