11-who-陈星宇

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1、PQGMPinspectionformedicinesOverviewXingyuChenInspectorPrequalificationTeam-InspectionsRegulationofMedicinesandHealthTechnologiesShanghai,20-22June20171

2、TITLEfromVIEWandSLIDEMASTER

3、June13,2017WHOGMPinspectionoverviewWHOGMP检查概览•Scope范围-API,FPP,原料药和制剂•Type类型oRoutine常规检查oNewsite新场地检查oDeskreview书面审查oFoll

4、owup跟踪检查oPre-inspection预检查2

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6、June13,2017WHOGMPinspectionoverviewWHOGMP检查概览Inspectionoutcome检查结果:
Compliant符合
DecisionmadeafterCAPAssubmittedandreviewed整改提交审查后决定
Non-compliant不符合3

7、TITLEfromVIEWandSLIDEMASTER

8、June13,2017WHOGMPinspectionoverviewWHOGMP检查概览
Inspectionclosinglet

9、ter检查关闭信
WHOpublicinspectionreportWHO检查公开报告
Noticeofconcern,ifnotcompliant.警告信,如果不符合。
Re-inspection:riskbased,max.3years复查，基于风险，最长3年。4

10、TITLEfromVIEWandSLIDEMASTER

11、June13,2017WHOFPPinspectionoverviewWHOFPP检查概览FPPinspections制剂检查
Year201329
Year201432
Year201524
Year2016385

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13、

14、June13,2017WHOFPP
-20166

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16、June13,2017WHOFPP
-2016FPPinspections2016percountry2.63%2.63%2.63%2.63%5.26%India5.26%China44.74%Kenya7.89%BrazilKoreaMaroccoFranceEqyptMexico26.32%7

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18、June13,2017WHOFPP
-20162016FPPsterile-nonstrile10NonsterileSterile

19、288

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21、June13,2017WHOAPIinspectionoverviewWHOAPI检查概览APIinspections原料药检查统计
Year201322
Year201432
Year201536
Year2016299

22、TITLEfromVIEWandSLIDEMASTER

23、June13,2017WHOAPI检查-2016常规检查1966%新场地检查621%书面审查13%跟踪检查310%10

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25、June13,2017WHOAPI
-2016Year2016APIinspe

26、ctions316RoutineNewsites19DeskreviewFollow-up11

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28、June13,2017WHOAPI检查-2016CountryNumberPercentageChina1448%India1448%Korea14%12

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30、June13,2017WHOAPI
-2016APIinspectionsprecountry201611414IndiaChinaKorea13

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32、June13,2017APID

33、eficienciesanalysis2016API缺陷分析2016API常见缺陷
Productqualityreview产品质量回顾
Productionandpackagingoperations生产和包装操作
Qualityriskmanagement质量风险管理
InvestigationofOOS不符合质量标准调查
Equipmentqualification–production生产