ICH六大系统检查内容

1、agenda议程comprehensive review with ref ere nee to fda's “six system compliance program manual: 与fda”六体系”顺应性程序手册相关的综合检查quality svstem - this system assures overall complianee with cgmps and internal procedures (sops) and specifications.质量体系系统确保要与cgmps, sops,及质量标准有总的顺应性a) fda compliance historyfda顺

2、应性历史b) quality control unit and all of its review and approval duties, including:质量控制部分和所有的冋顾及批准职责，包括：i)change control（变化控制）(1) changes to dmf or applicationdmf变更及申报ii)reprocessi ng返工iii)batch release批放行iv)annual record review年记录冋顾v)validation protocols and reports验证计划、方案和报vi)product defect evaluati

3、ons产品缺陷回顾(1) complaint file投诉档案vii) returned and salvaged goods evaluation产品退货及回收评估viii)table of organization组织机构图ix) curricula vitae of key personnel关键人员履历书x)sop indexsop索引xi) training program培训计划xii) internal audit program内部审计程序xiii)vendor qualification program客户确认程序(1) vendor audits客户审计facilities

4、 and equipment svstem - this system includes the measures and activities which provide an appropriate physical environment and resources used in the production of apts.设备和仪器系统-系统包括（捉供api产品所需的适当的自然环境和资源的）措施和活动c) buildings and facilities厂房和设施i) general tour甩、体布局ii) map / floor plan of plant layout工厂平面

5、布置图iii) maintenance维护iv) qualification确认v) monitoring监控d) equipment设备（仪器）i) qualification (installation, operation)确认（安装和运行）(1) note: performance qualification to be evaluated as part of process validation(see production system below).注：性能确认评估作为工艺验证的一部分ii) calibration校验iii) preventative maintenanee

6、program维护保养计划iv) cleaning清洁v) validation of cleaning processes, as appropriate 清洗程序适应性验证vi) use logs仪器设备使用纪录e) utilities that are not intended to be incorporated into the product公用设施i) hvac空调净化系统ii) compressed gases压缩气体iii) steam蒸汽iv) water systems水系统(1) validation验证(2) routine monitoring常规监测(a) che

7、mical purity化学纯度(b) microbial purity微牛物纯度materials system - this system in eludes measures and activities to control 物料系统系统包括措施和行为控制成品产品组件，包括容器包装f) finished productsg) comp on ents of the product, includingi) containersii) closuresiii) water水iv) gases气休h) raw material retest program原料的再检验程序i) valida

8、tion of computerized inventory control processes计算机存货系统的控制程序j) drug storage药品贮存i) temperature / humidity mapping and monitoring温度湿度图表和监控ii) bulk holding times studies贮存吋间研究k)distribution controls发放控制1)reserve sample program留样计划m) records记录production systems this includes measures and activities to c

9、ontrol the manufacture of apts, including:生产系统控制api生产的程序和措施n) batch compounding混批工艺流程图i) process flow chartso) in-process sampling and testing屮间取样和检验p) process validation工艺验证q) solve nt recovery溶剂回收r) approved, written manufacturing procedures工艺规程的起草和批准程序i) establishment of起草ii) following of审核批准iii)

10、 documenting performs nee of文件执行packaqinq and labelinq system this system includes measures and activities that control the packaging and labeling. it includes:包装和标签体系包括控制包装和标签的措施和行为的系统s) written procedures书面程序t) label examination and usage标签检查和使用u) label storage and issuance标签贮存和发放v) packaging and

11、labeling operations controls包装和标签的操作控制w) validation of these operations操作验证？ ？ ？x) lot numbering system批号编制化验室操作程序laboratory control system this system includes measures and activities related to 化验室控制体系x) laboratory proceduresi) sop for investigation of out of specification (oos) results oos调查的sop分

12、析操作技能培训计划检测及实验记录新进原材料中间体成品残留溶剂y)analyst training programz)testi ng and test recordsaa)i) incoming raw materialsii) intermediatesiii) finished productsiv) residual solventsv）lab notebooks - bound or loose sheetsiii) polymorphismiv) expiration dates冇效期实验记录一装订记录（批检验记录等）及零散记录bb)analytical methodology分析方法i) development开发ii) validation or verification验证cc) lab equipment实验室设备（仪器）i) qualification确认ii) maintenance 一 con tracts维护iii) calibration校验iv) use logs设备使用纪录dd)stability program稳定性程序i) ich