NH PHL Discipline D Special Project Track 3 Development and Validation

D类：特殊项目 途径3：方法开发和方法验证 NH PHL建议参加Elemental的短期多实验室验证 分析手册方法EAM 4.12：在本年度期间通过ICP-MS分析瓶装水 融资协议。NH PHL曾协助进行涉及美国FDA指南的既往研究 食品、饲料、化妆品和兽药中化学方法的验证，以及 充分了解参与本验证研究所需的程序。NH-PHL将 将参考方法加入或检测平台，并制备方法空白、基质 已知浓度的空白和基质加标，以显示耐用性、精密度、准确度， 选择性、检测限、定量限、线性、范围、测量不确定度， NH PHL生成的数据的耐用性、鉴别确认和加标回收率。 假阳性和假阴性率将使用其他验证人员共享的样本确定。 laboratories.所有业绩特征将与协助这一工作的其他伙伴分享。 验证研究，以提供总体方法的稳健统计数据。 NH PHL将参加与该项目有关的电话会议和每月的FERN电话会议，并保持 完成所提议工作所需的设施和人员。NH-PHL将保持 与FDA达成20.88协议。这项工作最后将在实况调查团面对面会议上介绍， 面对面会议，NH PHL将协助发表最终研究。

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.