Nanjing Simcere Dongyuan Pharmaceutical Co.,Ltd. 南京先声东元制药有限公司 Name: Validation Report Serial Nu mber: VR094-01 类 别：验证报告 报 告 号：VR094-01 Location: Instru ment Room of QC Page: No.1 of 8 安装位置：化验室 页 码：共8 页第1 页 Modified by 起 草 date 日期 Checked by EM dept. 工程部审阅 date 日期 Checked by QC dept. 质管部QC 审阅 date 日期 Checked by QA dept. 质管部QA 审阅 date 日期 Authorized by 批 准 date 日期 PerkinElmer Fou rier-transform Infrared Spectrophotometer Spectru m BXⅡ Operational And Performance Qu alification Report 傅立叶变换红外光谱仪运行及性能确认报告 (设备编号：DG0202147) PerkinElmer FT-IR Spectrum BX Ⅱ Operational and Performance Qualification Report Document NO.: VR094-01 PerkinElmer 傅立叶变换红外光谱仪 Spectrum BX Ⅱ运行及性能确认报告 报 告 号 : VR094-01 第 2 页 共 8 页 目 录 1 Equipment Description 设备描述 ............................................................................................. 3 2 History of Prequalification 前确认历史 ........................................................................................ 3 3 Spare Parts 仪器备品备件 ............................................................................................................ 3 4 Safety Inspection 安全检查 ......................................................................................................... 3 5 Verification of equipment 检验设备的校验 ................................................................................... 3 6 Calibration of instruments 仪表的校验 ........................................................................................ 4 7 SOP for OQ OQ 中所用标准操作规程 ........................................................................................ 4 8 Operating Qualification 运行确认...................................................
