药品稳定性试验箱验证方案QualificationProtocolforDrugStabilityTestChamberQC/EQP-013-01本文件须经过×××××药业股份有限公司授权方能复印！Thisdocumentcannotbeduplicatedwithouta×××××Pharm.Co.Ltd.AuthorizationREVIEWANDAPPROVALPAGEOFVALIDATIONPROTOCOLREVIEWANDAPPROVALOFVALIDATIONPROTOCOLPreparedby起草人Title职务Signature签名Date日期Reviewedby审核人Title职务Signature签名Date日期Approvedby批准人Title职务Signature签名Date日期目录TABLEOFCONTENTS1.验证目的（PURPOSE）...........................................................................................................................................42.引用标准（REFERENCEDOCUMENTATION）................................................................................................42.1环境试验设备温度、湿度校准规范JJF1101-2003.........................................................................................42.2稳定性试验箱操作规程QC071/CS/1................................................................................................................42.3稳定性试验箱校验规程QC072/CS/1................................................................................................................43.系统描述（SYSTEMDESCRIPTION）................................................................................................................44.职责（RESPONSIBILITIES）................................................................................................................................54.1检查者（OPERATOR）........................................................................................................................................54.2审核者（REVIEWER）........................................................................................................................................54.3负责人（MANAGER）........................................................................................................................................55.验证的管理（QUALIFICATIONMANAGEMENT）..........................................................................................65.1人员（PERSONNEL）..........................................................................................................................................65.2记录和数据（DATAASSEMBLY）......................................................................................................................65.3文件要求（DOCUMENTATIONREQUIREMENTS）...............................................................................................65.4偏差处理（DEVIATIONS）..................................................................................................................................65.5再验证（REQUALIFICATION）............................................................................................................................76.验证检查和测试（QUALIFICATION&TESTS）...............................................................................................86.1安装确认(INSTALLATIONQUALIFICATION,IQ)...................................................................................................86.2运行确认（OPERATIONQUALIFICATION,OQ）...............................................................................................106.3性能确认(PERFORMANCEQUALIFICATION,PQ)...........................................................
VIP
