理想的实验室操作下.ppt

理想的實驗室操作(下) Analytical Method 分析方法 Transfer, Verification, and Validation 转移、确认和验证 Method Transfer方法转移 The process to establish documented evidence that the analytical method works as well in the receiving laboratory as in the originators laboratory, or the transferring laboratory, is called Analytical method transfer. 用文件化的证明分析方法在接受实验室和原始实验 室或者转移实验室一致的程序叫做方法转移 Method Transfer方法转移 Regulatory testing requires that a transfer of analytical methodology from research development (RD) to quality control (QC), contract (e.g. CRO), or process laboratory is performed to ensure and certify that other laboratories are qualified to execute the method. 法规要求从研发到QC，合约实验室，或者中控实验室的分 析方法转移是为了确保和证明这些实验室有资质执行这个分 析方法 Method Transfer方法转移 ? Original laboratory provides a method validation report to receiving laboratory. 原始实验室提供给接收实验室一份方法验证报告。 ? After reading the report, the receiving lab writes a “Report Summary” and a “Method Transfer Protocol”. 收到报告后，接收实验室写一份“报告总结”和“方法转移方案” ? Then execute the transferring work. 然后执行方法转移工作。 ? Finally, document a “Method Transfer Report”. 最后，形成一份“方法转移报告”文件。 Method Transfer方法转移 Review the validation report from originating laboratory 回顾原始实验室提供的验证报告 – Assay conditions 含量条件 – Calculations 计算 – System suitability 系统适用性 ? Receiving laboratory should perform the method 接收实验室应按照分析方法执行。 – To determine whether there are differences and gaps in documentation 确认文件中是否存在差异和差别。 Method Transfer方法转移 ? Assess a subset of validation parameters 评估验证参数 – Equivalence Testing 等价性测试 ? Precision and Accuracy 精密度和准确度 – Key Attributes 关键的属性 ? Precision and Accuracy 精密度和准确度 ? LOD/LOQ 检测限和定量限 ? Identity 鉴别 ? Linearity 线性 Method Transfer方法转移 Typical Transfer should include: 典型的方法转移应该包括： – More than one lot of testing materials 超过一批产品的检测 ? Reference Standard(s) 工作标