Microbiology-PTM-OMA_Modules_1-5

Harmonization Studies: Overview

• What is a harmonization study? • A single validation that allows for certification from AOAC and an ISO 16140 approval  organization (AFNOR, MicroVal, NordVal).  • The study is designed to meet all the requirements need for certification including • Data requirements • Statistical analysis • Submission guidelines • The goal is to achieve optimal efficiency and avoid duplication of efforts in order  to meet regulatory and product safety testing requirements. • Reference standards • Testing requirements