FDA 验证目录.doc

第 1 页 共 9 页 一一 IQIQ OQOQ PQPQ 验证文件目录验证文件目录 1 Autoclave Installation Operational Qualification 高压灭菌器安装 操作确认 2 Autoclave Performance Qualification 高压灭菌器性能确认 3 Addendum To The Bio Freezer Installation Operational Qualification 生物冷冻 箱安装 操作确认附录 4 Bio Freezer Installation Operational Qualification 生物冷冻箱安装 操作确认最 终报告 5 Execution Approval Signatures 批准执行签名 6 Clean Steam Systerm Installation Qualification 洁净蒸汽系统安装确认 7 Addendum To The Clean Steam System Operational Qualification 洁净蒸汽系统操 作确认附录 8 Clean Steam System Operational Qualification 洁净蒸汽系统操作确认 9 Clean Steam System Installation Qualification 洁净蒸汽系统安装确认最终报告 10 Clean Stwam Sysem Operational Qualificaton 洁净蒸汽系统操作确认最终报告 11 To The Clean Steam System Operational Qualification 洁净蒸汽系统操作确认附 录最终报告 12 Compressed Air System Installation Operational Qualification 压缩空气系统安 装 操作确认 13 Compressed Air System Installation Operational Qualification 压缩空气系统安 装 操作确认最终报告 14 Day Heat Oven Installation Operational Qualification 干热灭菌柜安装 操作确 认 15 Day Heat Oven Installation Operational Qualification 干热灭菌柜安装 操作确 认最终报告 16 Hvac System K 1 Installation Operational Qualification HVAC 系统 K 1 安装 操作确认 17 Hvac PQ Enviromental Monitoring HVAC PQ 环境监测 18 Ntegrity Tester Installation Operational Qualification 完整性测试器安装 操 作确认 第 2 页 共 9 页 19 Installation Operational Qualification For The Lyopharma GLZ 12 Lyophilizer Automated Control System LYOPHARMA GLZ 12 型冻干机自控系统安装 操作确认 20 Lyophilizer 冻干机自控系统安装 操作确认文件 21 Installation Operational Qualification Of The Clean In Place Systrm CIP 系统安装 操作确认 22 Clean In Place System Installation Operational Qualification 在线清洗系统安 装 操作确认最终报告 23 Lyophilizer Installation Qualification 冻干机安装确认最终报告 24 Yophilizer Performance Qualification 冻干机性能确认最终报告 25 Installation Qualification Of The Lyophilizer 冻干机安装确认 26 Lyophilizer Operational Quaification 冻干机操作确认 27 Lyophilizer Performance Qualification 冻干机性能确认 28 Plant Steam System Installation Qualification 车间蒸汽系统安装确认 29 Plant Steam System Installation Qualification 车间蒸汽系统安装确认最终报告 30 Centrifuge Preventive Maintenance 离心机的预维护 31 Filter Press Preventive Maintenance 压滤机的预维护 32 Glycol System Preventive Maintenance 乙二醇系统预维护 33 Clean Steam Generator Preventive Maintenance 纯蒸汽发生器预维护 34 Air Compressor Preventive Maintenance 空气压缩机预维护 35 HEPA hood Preventive Maintenance 层流罩预维护 36 PW WFI System Preventive Maintenance PW WFI 系统预维护 37 HVAC Preventive Maintenance 空调系统预维护 38 Plant Steam Preventive Maintenance 工厂蒸汽系统预维护 39 Lyophilizer Preventive Maintenance 冻干机预维护 40 Mill Preventive Maintenance 粉碎机预维护 41 Vacuum Pump Preventive Maintenance 真空泵预维护 42 Balances Preventive Maintenance 天平预维护 43 Autoclave Preventive Maintenance 高压灭菌柜预维护 44 Biofreezer Preventive Maintenance 生物冷冻箱预维护 45 Dry Heat Oven Preventive Maintenance 干热灭菌柜预维护 第 3 页 共 9 页 46 PH Meter Preventive Maintenance pH 计预维护 47 Water Bath Preventive Maintenance 水浴预维护 48 Installation Operational Qualification For The Water For Injection AutomatedControl System 注射用水自控系统安装 操作确认最终报告 49 Installation Qualification Water For Injection System 注射用水系统安装确认 最终报告 50 Operational Qualification Water For Injection WFI System 注射用水 WFI 操 作确认最终报告 51 Performance Qualification For The Purified Water And Water For Injection WFI Ststem 纯化水和注射用水 WFI 系统性能确认最终报告 52 Installation Operational Qualification For The Water For Injection AutomatedControl System 注射用水自控系统安装 操作确认 53 Water For Injection WFI System Installation Qualification 注射用水 WFI 系 统安装确认 54 Water For Injection WFI System Operational Qualification 注射用水 WFI 系统操作确认 55 Performance Qualification For The Purified Water And Water For Injection WFI System 纯 化水和注射用水 WFI 系统性能确认 56 Verification Of The Suitability Of The Limulus Amebocyte Lysate Usp Monograph Method For Water 水的鲎变形细胞溶解产物 USP 专论方法适用性确认 二二 SOPSOP 标准操作程序文件目录标准操作程序文件目录 1 CZ 00 0001 SOP 标准操作程序 2 CZ 00 0002 Customer Vistors 公司访问人员 3 CZ 00 0003 Personal Sanitation 人员卫生 4 CZ 00 0004 Outside Contractors 外部承包商 5 CZ 00 0005 Good Documentation Practice 良好纪录规范 6 CZ 00 0006 Figures Rounding 有效数字和修约程序 第 4 页 共 9 页 7 CZ 00 0007 Signature Card 签名卡系统 8 CZ 00 0008 Pest Contro 害虫控制 9 CZ 00 0009 General Cleaning Instructions 一般清洗指导 10 CZ 00 0010 Audit Program 审计程序 11 CZ 00 0011 Computerized Systems Disaster Recovery And Contingency Plan 计算机化系统灾难恢复和应急计划 12 CZ 00 0012 Shutdown Program 停产期间的操作 13 CZ 10 0001 Receipt Handling And Storage Of Raw Materials 原料的接收 处理 和储存 14 CZ 10 0002 Raw Material And Inventory Contol 领用仓库原料申请 15 CZ 10 0003 Inventory Status Change 存货状态变化 16 CZ 10 0004 Stock Rotation 库存周转 17 CZ 10 0005 Fourth Shift Mrp 系统的原材料和成品放行 18 CZ 10 0006 product Inventory Control 成品存货控制 19 CZ 10 0007 Finished Product Labeling And Storage 成品贴标签和存放 20 CZ 10 0008 Packaging Shipping Of Finished Products 成品包装和运输 21 CZ 10 0009 Label Copy Receipt Control 标签复印和领取控制 22 CZ 20 0002 Cleaning And Operation Of 反应罐的清洗与操作 23 CZ 20 0005 Decanting Waste Aocohol 排废酒精 24 CZ 20 0006 Weighing Raw Material 原料称重 25 CZ 20 0007 Operation Of GQ 105 CENTRIFUGEGQ105 高速管式离心机的操作与 清洗 26 CZ 20 0008 Frame Filter Press Operation 板框压滤机的清洗和使用 27 CZ 20 0009 Operatioon Of Microfilter 微过滤器的操作 28 CZ 20 0010 Opeationofflowmeterandheat Exchangewfi 系统流量计与热交换器 的操作 29 CZ 20 0017 Scale And Balance Usage 生产区天平的使用 30 CZ 20 0018 Form 完整性测试仪使用记录 31 CZ 20 0018 Integrity Testing 密理博完整性测试仪的使用 32 CZ 20 0019 Operation Of WFIPW 纯水 注射用水系统的操作与每日维护 第 5 页 共 9 页 33 CZ 20 0021 Use And Storage Of WFI Transer Hose 溶液转移软管的使用与保存 34 CZ 20 0022 Operation Of Mixer 搅拌器的操作 35 CZ 20 0023 Operation Of Clean Steam Generator 纯蒸汽发生器的操作 36 CZ 20 0024 Tank Transfer 罐转移系统 37 CZ 20 0026 Daily Operation And Calibration Of PH meter FINALpH 计的日常 操作和校正 38 CZ 20 0030 Depyrogenation Oven 除热源烘箱的操作和清洗 39 CZ 21 0001 Personal Movement 生产区域人员着装 出入要求 40 CZ 21 0002 Material Movement 生产车间物流要求 41 CZ 21 0003 Singnatre On Production Documents 在生产文件上签名 42 CZ 21 0004 On the Job Training 岗位培训 43 CZ 21 0005 Cleaning Of Working Dress 工作服的清洗 44 CZ 21 0006 Cleaning For General Areas 厂房一般区域的清洁 45 CZ 21 0009 Clean up 生产区的清场 46 CZ 21 0011 Design And Construction Of Production Equipment 生产设备的设 计和构造 47 CZ 30 0002 Maintenance Work Order 维护工作请求程序 48 CZ 30 0003 Equipment ID 设备 ID 号 49 CZ 30 0004 PM Program 预维护程序 50 CZ 30 0006 Operation Of The HVAC K1HVAC 的操作 51 CZ 30 0007 Facility Interruption Program 公用工程中断应对程序 52 CZ 30 0008 Operation Of Glycol Chiller 乙二醇冷冻机的操作 53 CZ 30 0009 Sanitization Of The WFI systemWFI 系统的灭菌 54 CZ 30 0010 Operation 0f The Compressed Air System 空气压缩机系统操作 55 CZ 30 0011 Operation Of The Plant Steam 工厂蒸汽系统的操作 56 CZ 30 0012 Boiler Operation 锅炉操作程序 57 CZ 30 0015 Hardness Testing 水的硬度测定 58 CZ 30 0016 Engingering Drawing Manggement 工程图纸管理 59 CZ 30 0017 Data Backup And Security For WFI Control SystemWFI 系统的数 据备份及控制系统的权限设定 第 6 页 共 9 页 60 CZ 30 0017 Forms 备份记录和参数更改记录 61 CZ 30 0018 Data Backup And Security For Lyophilizer Control System 冻干机 系统数据备份及控制系统权限设定 62 CZ 40 0001 Quality Assurance 质量保证部门 63 CZ 40 0002 Alternate New Raw Material Vendor Approval 替换材料新材料卖主 批准 64 CZ 40 0004 Label Preparation Control 标签的制备及控制 65 CZ 40 0005 MI And Batch Record Control 生产工艺规程及批生产记录控制 66 CZ 40 0006 SOP TrainSOP 培训 67 CZ 40 0007 Product Investigation 产品调查 68 CZ 40 0008 Drug Recall Procedure 药品召回程序 69 CZ 40 0009 QA Inspection For ShippingQA 对发货进行检查 70 CZ 40 0010 Annual Product Review 年度产品回顾审查 71 CZ 40 0011 Material Status Label Control 物料状态标签的控制 72 CZ 40 0013 Reprocess 批生产的重加工程序 73 CZ 40 0014 Non conforming Yields 生产活动的趋势分析和不合格产率的调查程 序 74 CZ 40 0015 LABORATORY INVESTIGATIONS AND DATA HANDLING 调查 有计划的偏离 无计划的偏差的报告 75 CZ 40 0016 Customer Complaints 顾客投诉 76 CZ 40 0017 Certification Of Analysis COA 分析证书 77 CZ 40 0018 Product Return 产品退货 78 CZ 40 0019 Customer Purchase Specification 顾客的购买标准 79 CZ 40 0020 Training For New or Temporary Employees 新员工或临时工的培训 80 CZ 40 0021 Quarantine Rejected Material 隔离拒收材料 81 CZ 40 0022 Change Control 变更控制 82 CZ 40 0023 lot Numbering System 批号编号系统 83 CZ 40 0024 cGMP Training ProgramGMP 培训程序 84 CZ 40 0025 Statistical Verification Of Analyst Qualification 分析员资格 认定的统计验证 第 7 页 共 9 页 85 CZ 40 0026 Major Process Changes 重大工艺变更 86 CZ 40 0027 Quality Observation Reports 质量观察报告 87 CZ 40 0028 Treatment Of Product If WFI QOR Is Issued 签发 WFI 质量观察报 告后 对生产产品处置的程序 88 CZ 40 0029 Technology Transfer 技术转让 89 CZ 50 0002 Changing Of Compressed Gas Cylinders 压缩空气柱更换 90 CZ 50 0003 Operation Of Refrigerators Freezers And Ultra Low Temperature Freezers 冷冻器 冷却器和超低温度冷却器操作 91 CZ 50 0004 Daily Weight Verification Of Laboratory Balances 化验室天平每 日的砝码检定及操作 92 CZ 50 0005 Daily Operation And Ibration Of PH mMeters PH 计日常操作和校 验 93 CZ 50 0007 Retesting Inventory 存货重新测试 94 CZ 50 0008 实验室玻璃器皿清洗和存放 95 CZ 50 0009 Quality Control log in Procedure QC 登录程序 96 CZ 50 0010 Quality Control labaorataory Reagent Chemical And Analytical Reference Standards QC 实验室试剂化学品和分析参考标准溶液 97 CZ 50 0011 QC Sampling Inspection And Disposition Of Raw Materials FINAL 原料的取样 检查 处理和复检 98 CZ 50 0012 Stability Program Final 稳定性考察程序 99 CZ 50 0014 Finished Product Reserve Samples 成品保留样品 100 CZ 50 0015 ALI OOS 实验室调查和数据处理 101 CZ 50 0016 Assay Record Maintenance 化验记录保持 102 CZ 50 0017 Lab Analyst Training Program 实验室分析员培训程序 103 CZ 50 0019 TOC Analysis For Water Samples Draft2 水样的 TOC 检验 104 CZ 50 0022 Operation Of QC Laboratory Pipettors And Dispensers QC 实 验室吸移管管理器和分配器操作 105 CZ 50 0025 Submission Of To Contract Laboratories 向定约实验室提交样 品 106 CZ 50 0026 Calibration Of Genesys 10 Spectrophotometer 通用工程系统 10 第 8 页 共 9 页 分光光度计校验 107 CZ 50 0027 Calibration Of Laboratory Thermometers 实验室温度计校验 108 CZ 50 0028 Micropipette Calibration 微量吸移管校验 109 CZ 50 0031 Retention Samples 保存样品 110 CZ 50 0033 Temperature Humidity And Pressure Monitoring FINAL 温度 湿度和压力的监控 111 CZ 50 0033 Temperature Humidity And Pressure Monitoring FINAL 温度 湿度和压力的监控 112 CZ 50 0035 Laboratory Cleaning 实验室清洗 113 CZ 50 0036 Operation And Calibration Of The Eutech Cyberscan Con 500 Conductivity Meter 优利 Con 500 型电导率仪的操作和校正 114 CZ 50 0036 EUTECH CYBERSCAN CON 500 电导计操作和维护 115 CZ 50 0040 Operation and maintenance Of The Glassware Washer 玻璃器皿 清洗器操作和维护 116 CZ 50 0050 Incoming Calibration Of Volumetric Flask Traser Pipette And Buret 新入量瓶 吸移管和滴定管校验 117 CZ 50 0052 Technician And Laboratory Evaluation Program For Potencytt 技术员和实验室的效力评估程序 118 CZ 50 0053 Release Of Final Products FINAL 成品发货的 QA 检查 119 CZ 50 0053 Release Of Final Products 成品放行 120 CZ 50 0054 Qcquality Control Retest Procedure 重新测试程序 121 CZ 50 0057 Daily Monitoring For WFIPWWFI 的日常监控 122 CZ 51 0010 Chemistry Analysis Test For Purified Water For Injection 纯化水和注射用水化学分析 123 CZ 52 0001 Determination Of Loss On Drying 干燥失重测定法 124 CZ 60 0002 M