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2018-02-28 发布于江西
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STP-YZ402-00胆酸工艺验证方案.doc

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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·········································································