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FDA认证检查的六大系统

时间:2023-08-14   访问量:1174


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

1.12Validation: 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

2.4control 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

2.6lighting, 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

2.7sanitation 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

2.8 drawings (as built) 布局图(厂房)

II Equipment 设备

²equipment installation and operational qualification设备安装和运行确认

²adequacy of equipment design, size, material, construction and location 适当的设备设计、大小、材质、结构与位置²appropriate 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)

²cleaning procedures and cleaning validation清洁规程与清洁验证²controls 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

² 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²equipment 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

²control system for implementing changes in the equipment实施在设备方面发生的变更的控制系统

²equipment identification practices (where appropriate) 设备验收(如适用)

²documented 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

3.6representative 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 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

3.10rejection 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

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

3.12first 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

3.14water 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 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

3.17 finished 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

 

4 PRODUCTION SYSTEM生产系统

4.1 training/qualification 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和/或状态

4.5 calculation 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

4.6 complete 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, 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

4.10 final 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)

4.13 equipment cleaning and use logs 设备清洁与使用日志

4.14 master production and control records主要生产与控制记录(工艺规程)

4.15 batch production and control records批生产与控制记录

4.16process validation, including validation and security of computerized or automated processes 工艺验证:包括计算机化和自动化工艺的验证和安全

4.17 change control变更控制

4.18 documented investigation into any unexpected discrepancy记录任何未期望的不一致的调查

 

5 PACKAGING AND LABELING SYSTEM包装与标示系统

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

5.2acceptance operations for packaging and labeling materials适当的包装和标示材料的操作

5.3 control system for implementing changes in packaging and labeling operations实施在包装和标示操作方面所发生的变更的控制系统

5.4adequate storage for labels and labeling, both approved and returned after issued 标签和标示适当的贮存,包括已批准的和分发后退回的

5.5control of labels which are similar in size, shape, and color for different products对于不同的产品,标签在大小、形状和颜色相似方面的控制

5.6 label verification system标签确认系统

5.7 is gang printing used?使用大批量的印刷吗?

5.8adequate packaging records that will include specimens of all labels used 适当的包装记录,它应包括所有所用的标签的种类

5.9 control of issuance of labeling, examination of issued labels and reconciliation of used labels标示分发的控制,被分发的标签和被使用的标签的物料衡算

5.10 examination of the labeled finished product被标示的最终产品的检查

5.11adequate inspection (proofing) of incoming labeling进厂标示的适当的检查(校对)

5.12 use of lot numbers, destruction of excess labeling bearing lot/control numbers 批号的使用,多余的带有批号/控制号标示的销毁

5.13physical separation between different labeling and packaging lines在不同标示和包装线之间的物理的分隔

5.14monitoring of printing devices associated with manufacturing lines与生产线相关的打印装置的监测

5.15 line clearance, inspection and documentation生产线的清洁、检查和记录

5.16 adequate expiration dates on the label关于标签的适当的有效期

5.17 validation of packaging and labeling operations包装和标示操作的验证

5.18documented investigation into any unexpected discrepancy记录任何任何未期望的不一致的调查

 

6 LABORATORY CONTROL SYSTEM实验室控制系统

6.1training/qualification of personnel人员的培训/资质

6.2 adequacy of staffing for laboratory operations足够的实验室操作人员

6.3adequacy of equipment and facility for intended use适当的设备与设施

6.4 calibration and maintenance programs for analytical instruments and equipment分析仪器和设备的校准与维护保养

6.5validation and security of computerized or automated processes计算机化或自动化过程的验证和安全

6.6reference standards; source, purity and assay, and tests to establish equivalency to current official reference standards as appropriate对照标准品:来源、纯度和含量、以及为建立与目前官方的对照标准品等效所做的检测项目

6.7system suitability checks on chromatographic systems (e.g., GC or HPLC) 有关色谱系统(例如气相或高压液相)的系统适用性检查

6.8specifications, standards, and representative sampling plans质量标准、标准品和有代表性的取样计划

6.9 adherence to the written methods of analysis遵循书面的分析方法

6.10 validation/verification of analytical methods分析方法的验证/确认

6.11control system for implementing changes in laboratory operations 实施在实验室操作方面所发生的变更的控制系统

6.12Required testing is performed on the correct samples

对于正确的样品,执行所要求的检验

6.13documented investigation into any unexpected discrepancy 记录任何未期望的不一致的调查

6.14complete analytical records from all tests and summaries of results来自所有检验的完整的分析记录和结果的总结

6.15quality and retention of raw data (e.g., chromatograms and spectra)原始数据的质量和保存(例如色谱图和光谱图)

6.16correlation of result summaries to raw data; presence of unused data结果总结与原始数据的相关性,未使用的数据的存在

6.17adherence to an adequate Out of Specification (OOS) procedure which includes timely completion of the investigation遵循一个适当的OOS的规程,此规程包括调查的及时完成

6.18adequate reserve samples; documentation of reserve sample examination足够的留样、留样检查的文件

6.19stability testing program, including demonstration of stability indicating capability of the test methods稳定性检测的规程,包括检测方法的显示稳定性的证明


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