OMA Consulting Protocol Review: OMACON-2019-2

Table of Contents

1.0

Introduction 1.1

BIOMILK 300 LAC Method

1.2

Validation Overview

2.0

Method Developer Studies 2.1 Overview 2.2

Good Laboratory Practices

2.3 2.4 2.5 2.6 2.7 2.8 2.9

Safety

BIOMILK 300 LAC Methodology

Linearity

Interference and Cross Reactivity

Matrix Studies

Robustness

Stability and Lot-to-Lot

3.0

Report Format

Appendices

1. BIOMILK 300 LAC Instructions Manual 2. SMPR 2018.009 3. Report Format

2