无菌层流车IOQ实用模板.doc

实用标准文案 精彩文档 安装确认和运行确认方案 INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL 设备名称 Equipment Name 层流车2# Laminar car 2# 设备编码 Equipment ID 生产线 Production line 建筑楼 Building No  Prepared by 起草 Title 职务 Name 姓名 Signature 签字 Date 日期 生产 Production Reviewed by 审核 Title 职务 Name 姓名 Signature 签字 Date 日期 工程 Engineering 生产 Manufacturing 验证 Validation 质量 QA Approved by 批准 Title 职务 Name 姓名 Signature 签字 Date 日期 质量管理负责人 QP 修订历史纪录 Revision History Revision 版本 Revision Date 修订日期 Reason for Revision/Change Request 修订/更改要求的原因 Revised By 修订人 01 TABLE OF CONTENTS 目录 TOC \o 1-2 \h \z \u HYPERLINK \l _Toc333666637 1. 目的OBJECTIVE PAGEREF _Toc333666637 \h 6 HYPERLINK \l _Toc333666638 2. 确认范围QUALIFICATION SCOPE PAGEREF _Toc333666638 \h 6 HYPERLINK \l _Toc333666639 3. 系统描述SYSTEM DESCRIPTION PAGEREF _Toc333666639 \h 6 HYPERLINK \l _Toc333666640 4. 部门职责DEPARTMENTAL RESPONSIBILITIES PAGEREF _Toc333666640 \h 7 HYPERLINK \l _Toc333666641 4.1验证Validation PAGEREF _Toc333666641 \h 7 HYPERLINK \l _Toc333666642 4.2工程Engineering PAGEREF _Toc333666642 \h 7 HYPERLINK \l _Toc333666643 4.3生产Production PAGEREF _Toc333666643 \h 7 HYPERLINK \l _Toc333666644 4.4质量保证 Quality Assurances (QA) PAGEREF _Toc333666644 \h 7 HYPERLINK \l _Toc333666645 4.5质量管理负责人Qualified Person （QP） PAGEREF _Toc333666645 \h 8 HYPERLINK \l _Toc333666646 5. 接受标准ACCEPTANCE CRITERIA PAGEREF _Toc333666646 \h 8 HYPERLINK \l _Toc333666647 6. 总结报告SUMMARY REPORT RESULTS PAGEREF _Toc333666647 \h 8 HYPERLINK \l _Toc333666648 7. 实施和文件要求Implement and DOCUMENTATION REQUIREMENTS PAGEREF _Toc333666648 \h 8 HYPERLINK \l _Toc333666649 8. 培训确认/签名表PRE-QUALIFICATION TRAINING VERIFICATION/SIGNATURE LOG PAGEREF _Toc333666649 \h 9 HYPERLINK \l _Toc333666650 9. 检测仪器校准情况确认TEST INSTRUMENT CALIBRATION VERIFICATION PAGEREF _Toc333666650 \h 10 HYPERLINK \l _Toc333666651 10. 安装确认INSTALLATION QUALIFICATION PAGEREF _Toc333666651 \h 10 HYPERLINK \l _Toc333666652 10.1标牌及各部件安装确认Name Plate Data and Installation Qualificatio