标题：制药用水中总有机碳测定方法确认方案起 草：_______________________ 日期：______________ 初 审：_______________________ 日期： 审 核：_______________________ 日期： 批 准：_______________________ 日期： 分发部门：生效日期：质量保证部负责人：变更历史记录：文件名称文件编码生效日期变更原因制药用水中总有机碳测定方法确认方案V-MV·0529·00-PN/A 起草目录1背景和目的................................................................................................................................32人员及职责................................................................................................................................33定义............................................................................................................................................34验证总则....................................................................................................................................35参考文献....................................................................................................................................56实施方案....................................................................................................................................56.1验证前准备........................................................................................................................56.2操作....................................................................................................................................67偏差处理....................................................................................................................................97.1偏差记录............................................................................................................................97.2偏差处理跟踪....................................................................................................................9附表 1 人员确认..................................................................................
