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
Made with FlippingBook - Online catalogs