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1、文档供参考，可复制、编制，期待您的好评与关注！ 1QUALITY SYSTEM质量保证系统1.1Product reviews (annual) 产品审查(年度) 1.2Complaint reviews (quality and medical) 投诉审查(质量和医疗)1.3Discrepancy and failure investigations 不一致和失败的调查1.4Document Control 文件控制1.5Batch release 批放行1.6Change Control变更控制1.7Reprocess/Rework再加工/返工1.8Returns/Salvages 退回/
2、补救1.9Rejects 拒收1.10Stability Failures稳定性失败1.11Quarantine 待验1.12Validation: computer, equipment, process, laboratory methods, cleaning 验证：计算机、设备、工艺、实验方法、清洁1.13Training/qualification 培训/资质1.14internal Audit Program内审规程1.15Supplier Audit Program 供应商审计规程2FACILITIES AND EQUIPMENT SYSTEM 厂房设施与设备系统I Facili
3、ties 厂房设施2.1cleaning and maintenance 清洁与维护保养2.2facility layout and air handling systems厂房设施布局与空气处理系统2.3general air handling systems 全面的空气处理系统2.4control system for implementing changes in the building实施在厂房方面变更的控制系统2.5purified water and compressed air systems纯化水与压缩空气系统2.6lighting, potable water, washi
4、ng and toilet facilities, sewage and refuse -disposal照明、饮用水、清洗和盥洗设施、污水及垃圾处理2.7sanitation of the building, use of rodenticides, fungicides, insecticides, cleaning and sanitizing agents厂房卫生、灭鼠剂、杀真菌剂、杀虫剂、清洗剂及消毒剂的使用2.8drawings (as built) 布局图(厂房)II Equipment 设备equipment installation and operational quali
5、fication设备安装和运行确认adequacy of equipment design, size, material, construction and location 适当的设备设计、大小、材质、结构与位置appropriate use of equipment operations substances, (lubricants, coolants, refrigerants, etc.) contacting products/containers/etc. 适当的设备运行时接触产品/容器等物质的使用（例如，润滑剂、冷却剂、制冷剂等等）cleaning procedures an
6、d cleaning validation清洁规程与清洁验证controls to prevent contamination, particularly with any pesticides or any other toxic materials, or other drug or non-drug chemicals 预防污染的控制措施、尤其是杀虫剂或其它有毒物质、或其它药物与非药物化学物质qualification, calibration and maintenance of refrigerators and freezers 电冰箱和冷冻机的确认、校验和维护保养equipmen
7、t qualification, calibration and maintenance, including computer qualification/validation and security 设备确认、校准与维护保养，包括计算机确认/验证和安全control system for implementing changes in the equipment实施在设备方面发生的变更的控制系统equipment identification practices (where appropriate) 设备验收(如适用)documented investigation into any
8、unexpected discrepancy记录对任何未期望的不一致的调查3MATERIALS SYSTEM物料系统3.1training/qualification of personnel人员的培训/资质3.2identification of components, containers, closures组分、容器密封件的鉴定3.3inventory of components, containers, closures组分、容器密封件的目录3.4storage conditions贮存条件3.5storage under quarantine在隔离下的贮存3.6representat
9、ive samples collected, tested or examined using appropriate means 用适当的方法收集、检验和检查有代表性样品3.7at least one specific identity test is conducted on each lot of each component每个组分每一批，至少做一个专属性实验3.8a visual identification is conducted on each lot of containers and closures每批容器和密封件，应做一个目测确认3.9testing or valida
10、tion of suppliers test results for components, containers and closures对供应商的组分、容器和密封件的化验结果的检验或验证3.10rejection of any component, container, closure not meeting acceptance requirements不符合可接受要求的组分、容器和密封件的拒收3.11appropriate retesting/reexamination of components, containers, closures 组分、容器和密封件适当的复验/复查3.12f
11、irst in-first out use of components, containers, closures 组分、容器和密封件的先入先出3.13quarantine of rejected materials 拒收物料的隔离3.14water and process gas supply, design, maintenance, validation and operation 水与工艺用气的供应、设计、维护保养、验证和操作3.15control system for implementing changes in the materials handling operations
12、实施在物料处理操作方面所发生的变更的控制系统3.16qualification/validation and security of computerized or automated processes 计算机化或自动化过程的确认/验证和安全3.17finished product distribution records by lot 最终产品按批的销售记录3.18documented investigation into any unexpected discrepancy记录任何未期望的不一致的调查4PRODUCTION SYSTEM生产系统4.1training/qualificat
13、ion of personnel人员的培训/资质4.2control system for implementing changes in processes实施在工艺方面所发生的变更的控制系统4.3adequate procedure and practice for charge-in of components对于控制组分的适当的规程和操作4.4identification of equipment with contents, and where appropriate phase of manufacturing and/or status 装有内容物的设备的标注，以及适当的生产阶段
14、和/或状态4.5calculation and documentation of actual yields and percentage of theoretical yields 实际产率和理论产率百分数的计算与记录4.6complete batch production documentation全部的批生产记录4.7established time limits for completion of phases of production 针对生产阶段完成而制订的时间限度4.8implementation and documentation of in-process controls
15、, tests, and examinations (e.g., pH, adequacy of mix, weight variation, clarity)过程控制、检测和检查（例如pH、混合的充分、重量差异和透明度）的实施与记录4.9Justification and consistency of in-process specification and drug product final specifications 中间体的质量标准和成品的质量标准的合理性及其一致性4.10final specifications 最终的质量标准4.11prevention of objectionable microorganisms in non-sterile drug products 在非无菌产品中，有害微生物的预防4.12pre-processing procedures (e.g., set-up, line clearance, etc.) 前处理规程（例如安装，清场等）4.13equipment cleaning and use logs 设备清洁与使用日志4.14master production and control records主要生产与控制记录（工艺规程）4.15batch production and c
