快速诊断试剂厂房空调系统安装确认方案.docxVIP

快速诊断试剂厂房空调系统安装确认方案 GOLD-IQP-001 Installation Qualification Protocol for HVAC System of POCT Reagent Production Facility V1 PAGE 上海科华生物工程股份有限公司 Shanghai Kehua Bio-engineering Co.,Ltd PAGE 3/ NUMPAGES 114 姓名 Name 职务 Job Title 签字 Signature 日期 Date 起草人 Author 彭真Peng Zhen 工程基建部/Eng Dept验证专员/Validation Engineer 审核人 Reviewer(s) 顾毅斌 Gu Yibin 工程基建部/Eng.dept 总监/Director 张玉娴 Zhang Yuxian 质量保证部/QA POCT验证主管/POCTValidation Supervisor 罗春贞 Luo Chunzhen 质量保证部/QA 副总监/Vice Director 袁桃霞 Yuan Taoxia POCT生产/POCTMfg. 总监/Director 陈琳珏 Chen Linjue 质量控制部/QC 总监/Director 刘晓燕 Liu Xiaoyan 生产成品部/Packing dept. 总监/Director 批准人 Approver(s) 顾燕黎 Gu Yanli 质量副总经理 Quality Vice President 杭红 Hang hong POCT 项目负责人 POCT Project leader 生效日期 Valid From 修订记录Revisions Record 版本号 Version No. 修订描述 Description of Revision V1 新制订 Initial issuance 目录Index TOC \o 1-3 \h \z \u HYPERLINK \l _Toc392228732 1. 介绍Introduction PAGEREF _Toc392228732 \h 4 HYPERLINK \l _Toc392228733 1.1. 目的Purpose PAGEREF _Toc392228733 \h 4 HYPERLINK \l _Toc392228734 1.2. 系统描述SystemDescription PAGEREF _Toc392228734 \h 4 HYPERLINK \l _Toc392228735 1.2.1. 系统用途System Use PAGEREF _Toc392228735 \h 4 HYPERLINK \l _Toc392228736 1.2.2. 设计和运行特点Design and Operation Features PAGEREF _Toc392228736 \h 4 HYPERLINK \l _Toc392228737 1.2.3.能力Capability PAGEREF _Toc392228737 \h 9 HYPERLINK \l _Toc392228738 2. 范围Scope PAGEREF _Toc392228738 \h 12 HYPERLINK \l _Toc392228739 3. 法规/文件Regulation/Reference PAGEREF _Toc392228739 \h 12 HYPERLINK \l _Toc392228740 3.1. 法规Regulation PAGEREF _Toc392228740 \h 12 HYPERLINK \l _Toc392228741 3.2. 操作规程SOP PAGEREF _Toc392228741 \h 12 HYPERLINK \l _Toc392228742 3.3. 验证相关文件Document related to validation PAGEREF _Toc392228742 \h 13 HYPERLINK \l _Toc392228743 4. 定义与缩写Definition and abbreviation PAGEREF _Toc392228743 \h 13 HYPERLINK \l _Toc392228744 5. 职责Responsibility PAGEREF _Toc392228744 \h 14 HYPERLINK \l _Toc392228745 6.验证步骤Validation steps PAGEREF _Toc392228745 \h 15 HYPERLINK \l _Toc392228746