第1页共70页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第1页共70页PHARMACEUTICALINSPECTIONCONVENTIONPHARMACEUTICALINSPECTIONCO-OPERATIONSCHEME药品检验公约药品检验合作计划GUIDETOGOODMANUFACTURINGPRACTICEFORMEDICINALPRODUCTSPARTI药用产品良好生产规范指南第一部分目录第一章质量管理............................................................................................................................2第二章人员....................................................................................................................................11第三章厂房设施..........................................................................................................................17第四章文件..................................................................................................................................25第五章生产..................................................................................................................................41第六章质量控制............................................................................................................................53第七章委托生产与委托检验......................................................................................................62第八章产品投诉和召回..............................................................................................................66第九章自检..................................................................................................................................69第2页共70页第1页共70页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第2页共70页CHAPTER1第一章质量管理QUALITYMANAGEMENTPRINCIPLE原则Theholderofamanufacturingauthorisationmustmanufacturemedicinalproductssoastoensurethattheyarefitfortheirintendeduse,complywiththerequirementsoftheMarketingAuthorisationanddonotplacepatientsatriskduetoinadequatesafety,qualityorefficacy.Theattainmentofthisqualityobjectiveistheresponsibilityofseniormanagementandrequirestheparticipationandcommitmentbystaffinmanydifferentdepartmentsandatalllevelswithinthecompany,bythecompany’ssuppliersandbythedistributors.ToachievethequalityobjectivereliablytheremustbeacomprehensivelydesignedandcorrectlyimplementedsystemofQualityAssuranceIncorporatingGoodManufacturingPractice,andthusQualityControlandQualityRiskManagement.Itshouldbefullydocumentedanditseffectivenessmonitored.AllpartsoftheQualityAssurancesystemsshouldbeadequatelyresourcedwithcompetentpersonnel,andsuitableandsufficientpremises,equipmentandfacilities.Thereareadditionallegalresponsibilitiesfortheholderofthemanufacturingauthorisationandfortheauthorisedperson(s).生产许可证持有人必须生产药品，从而确保药品适合预期用途、符合相应的上市许可证或临床试验许可证要求，不因为安全性问题、质量问题或有效性问题而把患者置于风险之中实现上述质量目标是公司高级管理人员的职责，并要求公司的供应商、销售商，公司内所有各级员工与许多不同部门的员工共同参与、一起努力。要可靠地实现这一质量目标，必须综合设计一个整合药品生产质量管理规范（GMP）和质量控制、质量风险管理的制药质量保证体系并正确实施。质量体系应当全面文件化，并监察其有效性。整个制药质量体系应当配备充足的具有资质的人员，以及充分并适用的建筑物、设备和设施。生产许可证持有人以及质量受权人有额外的法律责任。ThebasicconceptsofQualityAssurance,GoodManufacturingPractice,QualityControlandQualityRiskManagementareinter-rela...
