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STP-YZ402-00胆酸工艺验证方案
胆酸工艺验证起 草 人：审 核 人： 批 准 人： 起草部门： 起草日期： 审核日期： 批准日期： 执行日期： 部 门 岗 位 签 名 签名日期 颁发部门Copy №： [ ] 质量部QA[ ] 生技部[ ] 物流部 ] 研发部[ ] 行政部[ ] 工程部[ ]
质量部QC[ ] 一车间[ ] 二车间[ ] 三车间[ ] 营销部[ ] 档案室[ 1] 变更记载：
修订号 批准日期 执行日期
00 变更原因及目的：
建立验证文件，并通过验证证明所验证对象有效、稳定、可靠。
目 录
验证方案·································································································································3
1 概述·······························································································································2 目的·······························································································································
3 职责·······························································································································
4验证工艺规程编码·······························································································4
5验证批量·······················································································································4
6 工艺流程图······················· ···············································································································4
7 原材料清单······················· ··············································································································6
8 生产设备清单···································································································································6
9 关键工艺质量控制点·······················································································································6
10 验证执行的相关文件·····················································································································7
11生产过程参数确认··························································································································8
12验证工序及内容·········································································
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