1 ****制药有限公司 方案名称： TOC 测定清洁方法验证方案 方案登记号：MVa-P0012-00 2 验证方案目录 1 .验证方案审批 ................................................................................................................................... 3 2 .验证概述 ........................................................................................................................................... 4 3 .验证目的 ........................................................................................................................................... 4 4 .验证范围 ........................................................................................................................................... 4 5 .验证日期 ........................................................................................................................................... 4 6 .验证组织及职责分工及资格确认 ................................................................................................... 4 7 .验证用仪器及校正 ........................................................................................................................... 5 8 .设备清洗残留微检查（总有机碳测定）方法验证准备 ............................................................... 5 9 .系统适用性实验 ............................................................................................................................... 6 10.线性 ................................................................................................................................................ 7 11.准确度 ............................................................................................................................................ 7 12 重复性 ............................................................................................................................................ 8 1 3 棉签擦拭法取样回收率试验 ................................................
