某公司已过新版GMP认证洁净厂房验证模版(中英文)VIP专享VIP免费

*******************公司文件编号**********************公司口服固体项目页码1of32CleanRoomInstallationQualificationProtocol洁净室安装确认方案CleanRoomInstallationQualificationProtocol洁净室安装确认方案SystemNo.系统编号:CLR-01ApprovalforProtocol方案批准Company/Title公司/职务Name姓名Signature签名Date日期Writtenby起草Reviewedby审核Approvedby批准Revision版本Issueddate颁布日期Reasonfornewissue颁布原因REV.00Initialissue首次发布*******************公司文件编号**********************公司口服固体项目页码2of32CleanRoomInstallationQualificationProtocol洁净室安装确认方案Index目录1.PURPOSE目的............................................................................................................................32.SCOPE范围.................................................................................................................................33.RESPONSIBILITY职责................................................................................................................34.REGULATIONANDGUIDANCE法规和指南..............................................................................35.ABBREVIATIONS缩略语.............................................................................................................46.SYSTEMDESCRIPTION系统描述.............................................................................................47.GOODDOCUMENTATIONPRACTICE文件管理规范................................................................58.TESTLIST测试列表....................................................................................................................69.PERSONNELIDENTIFICATION人员确认..................................................................................710.PROCEDURE过程......................................................................................................................810.1先决条件...........................................................................................................................810.2文件确认.........................................................................................................................1010.3图确认.............................................................................................................................1110.4房间组件检查..................................................................................................................1410.5仪器仪表校验..................................................................................................................1610.6洁净室建造装修检查.......................................................................................................1910.7电器安装检查..................................................................................................................2311.DEVIATIONREPORT偏差报告.................................................................................................29*******************公司文件编号**********************公司口服固体项目页码3of32CleanRoomInstallationQualificationProtocol洁净室安装确认方案1.Purpose目的本安装确认方案的目的是测试、检查和洁净室是按照相应设计要求和供应商的建议进行安装的。安装确认的测试和检查的结果将按照该验证方案进行记录。安装确认将确定直接影响系统的关键部件被正确地安装，并符合设计文件需求；确定支持文件、质量文件在现场。测试和检查的结果将按照该验证方案进行记录。2.Scope范...