AOAC GFA Stakeholder Program Meeting Book (March 17, 2021)

What We Like • Guidance

• Technical course • Published guidance documents & Appendices • Specific SMPRs

• Statistically sound criteria • Some commercially available CRMs • Some reference materials targeted at spiking or creating incurred matrices • Energy/enthusiasm around this program launch

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NEOGEN had a PTM project that took 1 full year to get a protocol approval, which is typically a 3-6 week process. A couple of representative issues: • Change in spike protocol after study was initiated • Uncertainty over whether it would be implemented • Former homogeneity criteria are not relevant for new spike protocol • Had to discard collected surface and specificity data • Had to repeat feasibility study (which we do prior to application)

A PTM Case Study

• Change in spike material after study was initiated • Uncertainty on how reference method should be used • 3 months for initial expert review

PTM Number Awarded

Protocol Writing

Protocol Approval

Report Writing

Report Approval

Application

Testing

©2020 NEOGENCorporation. All rights reserved.

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