Microbiology-PTM-OMA_Modules_1-5

Harmonization Studies: Application Process

MicroVal • MicroVal Secretariat will assign two members  of the Technical Committee (MVTC) to each  protocol for review • Entire TC is allowed to review and provide  feedback • Protocol review, comments and responses all  take place on electronic forum or in person • A pre‐study conference call to discuss project  in details is conducted • Feedback from MVTC and responses to protocol  are presented • Protocol is revised and a second review is  conducted • Once protocol is approved Expert Lab is ready  to begin validation study

ISO 16140 • Contract with Expert Lab to prepare protocol  for submission to MicroVal, AFNOR or  NordVal • Specific templates must be followed  • Expert Lab will review protocol with AOAC TC  to ensure continuity between protocols • Expert Lab will submit to certifying body