NH PHL Discipline D Special Project Track 3 Development and Validation

学科D：特别项目 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：本年度第一年瓶装水的电感耦合等离子体质谱分析 资金协议。NH PHL曾协助过涉及美国FDA指南的先前研究 食品、饲料、化妆品和兽医产品中化学方法的验证，以及 深知参与本次验证研究所需的程序。NH PHL将 将参考方法合并到或测试平台上，并准备方法空白、矩阵 已知浓度的空白和矩阵尖峰，以显示稳健性、精密度、准确性、 选择性、检出限、定量限、线性、范围、测量不确定度、 由NH PHL生成的数据的坚固性、身份确认和峰值恢复。 将使用由其他验证共享的样本来确定假阳性率和假阴性率 实验室。所有性能特征都将与协助完成此任务的其他合作伙伴共享 验证研究，以提供关于该方法的总体可靠统计数据。 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 完成拟议工作所需的设施和人员。NH PHL将保持一个 与FDA达成的20.88有效协议。这项工作最终将在LFFM面对面展示 面对面会议，国家公共图书馆将协助发表最终研究报告。

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.