Special Project Method Development and Method Validation Analytical Track

提高能力和容量 微生物和化学检测支持 食品防务与食品安全一体化体系 特殊项目规程、方法开发和方法验证 分析轨道 项目摘要/摘要 方法开发和方法验证是生产新的检测方法的关键 以及分别提供可辩护的方法以支持任何相应的监管行动。 单一实验室验证(SLV)和多实验室验证成功的常见障碍 验证(MLV)研究是指糟糕的实验设计导致无法使用验证 数据或协调多个实验室和标准化整个方法的高成本 国内甚至国际航线。在这两种情况下，这些研究都需要大量的投资 每个参与实验室的时间。然而，验证研究的好处是值得的。 所涉及的成本。俄亥俄州农业部(ODA)消费者保护 因此，实验室(CPL)建议在第一个项目期参与多个实验室 FDA元素分析手册方法EAM 4.12的验证(MLV)研究 瓶装水中18种元素的光谱分析Oda-cpl将提供所有 必要的试剂、经验丰富的人员和后勤支持，以确保他们的实验室 部分工作已经完成。官方发展援助-CPL将参与任何与 MLV。在今后的项目期间，官方发展援助--CPL打算继续制定方法和 进行微生物或化学研究的方法验证活动和申请 方法取决于FDA的优先事项，只要oda-cpl的资产和工作流程 兼容。

Increasing the Capability and Capacity of Microbiological and Chemical Testing to Support an Integrated Food Defense and Food Safety System Special Projects Discipline, Method Development and Method Validation Analytical Track Project Summary / Abstract Method development and method validation are vital to the production of new testing assays and providing defensible methods to support any corresponding regulatory action, respectively. Common prohibitors of successful single laboratory validation (SLV) and multi-laboratory validation (MLV) studies are that of poor design of experiment leading to unusable validation data or the high cost of coordinating multiple laboratories and standardizing the method across national or even international lines. In both cases these studies require a large investment of time for each participating laboratory. Nevertheless, the benefits of a validated study are worth the costs involved. The Ohio Department of Agriculture (ODA) Consumer Protection Laboratory (CPL) thus proposes in the first project period to participate in a multi-laboratory validation (MLV) study for the FDA Elemental Analysis Manual method EAM 4.12, “Mass Spectrometric Determination of 18 Elements in Bottled Water.” ODA-CPL will supply all necessary reagents, experienced personnel and logistical support to ensure their laboratory portion of work is complete. ODA-CPL will participate in any communications related to the MLV. In future project periods, ODA-CPL intends to continue method development and method validation activities and applying to perform studies for microbiological or chemical methods depending on FDA’s priorities so long as ODA-CPL’s assets and workflow are compatible.