AOAC GFA Stakeholder Program Meeting Book (August 29, 2021)

• Initial Priorities: o Guidance document for validation criteria

വ Example elements: acceptance criteria, acceptable testing materials, standardization of units/define conversion factors o Guidance document for end users വ Example elements: comparing methods, fit-for-purpose identification, guidance on implementation, sampling instructions o Criteria for testing and reference materials; testing materials for method o Positioning methods in relation with health significance of results e.g. in relation with hazard characterization aspects - VITAL numbers, health needs vs. method practicality/standardized reporting units • Future priorities: o Identify need for new SMPRs o Review of new/updated regulatory requirements developers for validation vs. materials for QC o New generation allergens/novel ingredients

Food Allergen Working

Group Scope

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Target audiences • Method developers • Independent laboratories • Immunoassay methods • Quantitative and qualitative methods

Objectives • Fill the gaps in existing guidance • Update existing guidance where best practices have changed • Support existing and future SMPRs

Content

• Testing

materials • Reporting units • Study protocol designs • Acceptance criteria

Draft Validation Guidance on Food Allergen Immunoassays

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