缬沙坦手性异体验证方案20150118.docVIP

题 目 Title 缬沙坦手性异构体检验方法验证 文件编号 Document No. 版 本 号 Revision 00 版本历史记录/ Revision History 版本Revision 变更Change 签名Signature 日期Date 00 新建 EXECUTION APPROVAL SIGNATURES 批准执行签名 下面的签名表示批准本文件及其附件，可以执行方案。 These signatures below mean this document and attachment have been approved to perform this protocol. 职能Responsibility 姓名 Name 部门 Department 签名/日期 Signature and Date 编制 Prepared by 质量控制部 审核 Reviewed by 质量控制部 审核 Reviewed by 质量保证部 审核 Reviewed by 质量保证部 批准人 Approved by: 质量部 签名表SIGNATURE TABLE 所有执行和审核此方案并进行签名的人员必须填写以下表格。此表可根据草签或签名追踪到其人,填写以下表格表明执行测试的人员已经理解了方案的要求并且可以执行方案。 All the personnel to perform and review this protocol must fill in the following form. This form can show they have understood the procotol requirement and will strictly implement it. 姓名 Name 职务 Title 签名 Signature 日期 Date 验证小组组长Validation Team Leader 验证小组成员Validation Team Member  目录 TOC \o 1-3 \h \z \u HYPERLINK \l _Toc381788305 1. 概述INSTRODUCTION PAGEREF _Toc381788305 \h 5 HYPERLINK \l _Toc381788306 2. 目的/PURPOSE PAGEREF _Toc381788306 \h 5 HYPERLINK \l _Toc381788307 3. 范围/SCOPE PAGEREF _Toc381788307 \h 5 HYPERLINK \l _Toc381788308 4. 检验方法描述/ TEST METHOD DESCRIPTION PAGEREF _Toc381788308 \h 5 HYPERLINK \l _Toc381788309 5. 职责/RESPONSIBILITY PAGEREF _Toc381788309 \h 7 HYPERLINK \l _Toc381788310 6. 参考文件/ REFERANCES PAGEREF _Toc381788310 \h 7 HYPERLINK \l _Toc381788311 7. 缩略语/ABBREVIATIONS PAGEREF _Toc381788311 \h 7 HYPERLINK \l _Toc381788312 8. 测试/TEST PAGEREF _Toc381788312 \h 7 HYPERLINK \l _Toc381788313 9. 偏差列表/DEVATIONS LIST PAGEREF _Toc381788313 \h 9 HYPERLINK \l _Toc381788314 10. 变更清单/CHANGE LIST PAGEREF _Toc381788314 \h 10 HYPERLINK \l _Toc381788315 11. 结论/建议 CONCLUSION/RECOMMENDATION PAGEREF _Toc381788315 \h 11 HYPERLINK \l _Toc381788316 12. 报告的审批/REPORT APPROVAL PAGEREF _Toc381788316 \h 12 HYPERLINK \l _Toc381788317 13. 附件/ATTACHMENT PAGEREF _Toc381788317 \h 13 HYPERLINK \l _Toc381788318 附件1—SOP确认 PAGEREF _Toc381788318 \h 14 HYPERLINK \l _Toc381788319 附件2—培训的确认 P