Microbiology-PTM-OMA_Modules_1-5

Harmonization Studies: Overview

• Combines aspects of AOAC PTM and AOAC OMA programs  that are also required for ISO 16140 • Inclusivity & Exclusivity • Matrix studies (referred to RLOD studies in ISO) • Interlaboratory study • Matrix studies, inclusivity & exclusivity, and ILS are conducted  by the Expert Lab, no internal data is allowed (16140  requirement) • Since all matrix study work is done by the Expert Lab, an additional  independent lab study is not required for PTM • Additional PTM studies (lot‐to‐lot, stability, robustness,  instrument variation) are performed by the method developer • Data not submitted as part of ISO 16140 certification • Stability, lot‐to‐lot covered under manufacturing standard