P08紫外灯验证PQ方案.doc

再确认方案 REQUALIFICATION PROTOCOL 设备名称 Equipment Name 紫外灯 UV lamp 设备编码 Equipment ID 生产线 Production line  起草Prepared by 职务 Title 姓名 Name 签字 Signature 日期 Date 生产 Production 审核Reviewed by 职务 Title 姓名 Name 签字 Signature 日期 Date 生产 Production 验证 Validation 质量 QA 批准Approved by 职务 Title 姓名 Name 签字 Signature 日期 Date 质量管理负责人 Qualified Person  修订历史纪录 Revision History 版本Revision 修订日期Revision Date 修订/更改要求的原因 Reason for Revision/Change Request 修订人 Revised By 01 新制订 02 年度再验证 TABLE OF CONTENTS 目录 TOC \o 1-2 \h \z HYPERLINK \l _Toc342555991 1. 目的PURPOSE PAGEREF _Toc342555991 \h 5 HYPERLINK \l _Toc342555992 2. 系统概述SYSTEM DESCRIPTION PAGEREF _Toc342555992 \h 5 HYPERLINK \l _Toc342555993 3. 缩写与定义ABBREVIATIONS TERMS PAGEREF _Toc342555993 \h 5 HYPERLINK \l _Toc342555994 4. 职责RESPONSIBILITIES PAGEREF _Toc342555994 \h 5 HYPERLINK \l _Toc342555995 4.1 生产Production PAGEREF _Toc342555995 \h 5 HYPERLINK \l _Toc342555996 4.2 质量控制（QC） Quality Control (QC) PAGEREF _Toc342555996 \h 6 HYPERLINK \l _Toc342555997 4.3 质量保证（QA）Quality Assurance (QA) PAGEREF _Toc342555997 \h 6 HYPERLINK \l _Toc342555998 4.4 质量受权人（QP）Qualified Person (QP) PAGEREF _Toc342555998 \h 6 HYPERLINK \l _Toc342555999 5. 总结报告SUMMARY REPORT RESULTS PAGEREF _Toc342555999 \h 6 HYPERLINK \l _Toc342556000 6. 实施和文件要求Implement and DOCUMENTATION REQUIREMENTS PAGEREF _Toc342556000 \h 6 HYPERLINK \l _Toc342556001 7. 相关文件确认Related Documents Verification PAGEREF _Toc342556001 \h 7 HYPERLINK \l _Toc342556002 8. 设备状态回顾MACHINE STATUS REVIEW PAGEREF _Toc342556002 \h 8 HYPERLINK \l _Toc342556003 9. 培训确认/签名表PRE-QUALIFICATION TRAINING VERIFICATION/SIGNATURE LOG PAGEREF _Toc342556003 \h 9 HYPERLINK \l _Toc342556004 10. 再验证REQUALIFICATION PAGEREF _Toc342556004 \h 10 HYPERLINK \l _Toc342556005 10.1 测试仪器校准确认Test Instrument Calibration Verification PAGEREF _Toc342556005 \h 10 HYPERLINK \l _Toc342556006 10.2 验证物料清单确认Validation Material List Verification PAGEREF _Toc342556006 \h 11 HYPERLINK \