FDA认证检查的六大系统

1 QUALITY SYSTEM质量保证系统

1.1 Product reviews (annual) 产品审查(年度)

1.2 Complaint reviews (quality and medical) 投诉审查(质量和医疗)

1.3 Discrepancy and failure investigations 不一致和失败的调查

1.4 Document Control 文件控制

1.5 Batch release 批放行

1.6 Change Control变更控制

1.7 Reprocess/Rework再加工/返工

1.8 Returns/Salvages 退回/补救

1.9 Rejects 拒收

1.10 Stability Failures稳定性失败

1.11 Quarantine 待验

1.12 Validation: computer, equipment, process, laboratory methods, cleaning 验证：计算机、设备、工艺、实验方法、清洁

1.13 Training/qualification 培训/资质

1.14 internal Audit Program内审规程

1.15 Supplier Audit Program 供应商审计规程

2 FACILITIES AND EQUIPMENT SYSTEM 厂房设施与设备系统

I Facilities 厂房设施

2.1 cleaning and maintenance 清洁与维护保养

2.2 facility layout and air handling systems厂房设施布局与空气处理系统

2.3 general air handling systems 全面的空气处理系统

2.4 control system for implementing changes in the building实施在厂房方面变更的控制系统

2.5 purified water and compressed air systems纯化水与压缩空气系统

2.6 lighting, potable water, washing 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

2.7 sanitation 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

2.8 drawings (as built) 布局图(厂房)

II Equipment 设备

"equipment installation and operational qualification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 and 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

"equipment 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 unexpected discrepancy记录对任何未期望的不一致的调查

3 MATERIALS SYSTEM物料系统

3.1 training/qualification of personnel人员的培训/资质

3.2 identification of components, containers, closures组分、容器密封件的鉴定

3.3 inventory of components, containers, closures组分、容器密封件的目录

3.4 storage conditions贮存条件

3.5 storage under quarantine在隔离下的贮存

3.6 representative 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

3.7 at 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

3.8 a 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

3.9 testing or validation of supplier's 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

3.10 rejection 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

3.11 appropriate retesting/reexamination of components, containers, closures 组分、容器和密封件适当的复验/复查

3.12 first in-first out use of components, containers, closures 组分、容器和密封件的先入先出

3.13 quarantine of rejected materials 拒收物料的隔离

3.14 water 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

3.15 control system for implementing changes in the materials handling operations 实施在物料处理操作方面所发生的变更的控制系统

3.16 qualification/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