NH PHL Discipline D Special Project Track 3 Development and Validation

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Discipline D: Special Projects Track 3: Method Development and Method Validation The NH PHL proposes to take part in a short-term multi-laboratory validation of Elemental Analysis Manual method EAM 4.12: analysis of bottled water by ICP-MS during Year 1 of this funding agreement. NH PHL has assisted in previous studies involving the U.S. FDA's Guidelines for the Validation of Chemical Methods in Food, Feed, Cosmetics, and Veterinary Products, and is well aware of the procedures required to take part in this validation study. The NH PHL will incorporate the reference method onto or testing platform, and prepare method blanks, matrix blanks and matrix spikes of known concentrations to show the robustness, precision, accuracy, selectivity, limit of detection, limit of quantitation, linearity, range, measurement uncertainty, ruggedness, confirmation of identity and spike recovery of the data generated by the NH PHL. False positive and negative rates will be determined using samples shared by other validating laboratories. All performance characteristics will be shared with other partners assisting in this validation study to provide robust statistics on the method overall. NH PHL will attend conference calls relating to this project and monthly FERN calls, and maintain facilities and personnel necessary to complete the work proposed. The NH PHL will maintain a valid 20.88 agreement with the FDA. This work would finally be presented at the LFFM Face-to- Face meeting, and NH PHL would assist with publication of the final study.