多功能提取灌清洁验证方案.pdf

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1、贵州宏奇药业有限公司(TQ-3M3)多功能提取罐清洁验证目录第一部分验证方案YZ-JB-15001....................................................................................................................................................31、概述：......................................................................

2、......32、验证目的....................................................................................................................................................33.验证范围.........................................................................................................

3、..............................................34.验证组织与取责...........................................................................................................................................44.1验证小组成员及职责................................................................4

4、5、验证条件：................................................................................................................................................66、验证可接受标准：...............................................................................................................

5、.....................66.1物理外观检查：不得有可见的残留痕迹。..............................................66.2主要活性成份残留量可接受标准：最低日治疗剂量的1/1000。............................66.3冲洗液PH值应与饮用水PH值一致（即二者相差在±0.2之间）.............................66.4、活性成分残留的验证：............................................

6、................66.4.1产品分析：..............................................................................................................................66.4.1.1产品主药在水中溶解性：.....................................................................................................

7、...........66.5.2产品选择：......................................................................66.5.3设备最难清洗部位：..............................................................76.5.4产品数据统计：..................................................................76.5.4以残留限度最低日治疗量的1/1000计

8、算可接收标准计算公式:...........................86.5.7可接受残留污染量的标准确定：...............................