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药品生产质量管理规范（2010年修订）（卫生部令第79号）GoodManufacturingPracticeforPharmaceuticalProducts[MOHOrder#79]-Amendedin20102011年02月12日发布中华人民共和国卫生部令第79号《药品生产质量管理规范（2010年修订）》已于2010年10月19日经卫生部部务会议审议通过，现予以发布，自2011年3月1日起施行。部长陈竺二○一一年一月十七日第一章总则Chapter1GeneralProvisions第一条为规范药品生产质量管理，根据《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》，制定本规范。Article1:ThisRegulationisenactedinaccordancewiththeDrugAdministrationLawofThePeople'sRepublicofChinaand”RegulationforimplementationofDrugAdministrationLaw”第二条企业应当建立药品质量管理体系。该体系应当涵盖影响药品质量的所有因素，包括确保药品质量符合预定用途的有组织、有计划的全部活动。Article2:Pharmaceuticalcompaniesshouldestablishaqualitymanagementsystem.Thesystemshouldcoverallthefactorsthataffectthedrugquality,includingallorganizedandplannedactivitiestoensurethequalityofmedicinesmeetingtheintendeduse.第三条本规范作为质量管理体系的一部分，是药品生产管理和质量控制的基本要求，旨在最大限度地降低药品生产过程中污染、交叉污染以及混淆、差错等风险，确保持续稳定地生产出符合预定用途和注册要求的药品。Article3:GoodManufacturingPracticeisthatpartofQualityAssurance,whichensuresthatproductsareconsistentlyproducedandcontrolledtothequalitystandardsappropriatetotheirintendeduseandasrequiredbytheMarketingAuthorisationorproductspecification.第四条企业应当严格执行本规范，坚持诚实守信，禁止任何虚假、欺骗行为。Article4:ThepharmaceuticalenterpriseshouldfollowGoodManufacturingPracticestrictly.第二章质量管理Chapter2QualityManagement第一节原则Section1Principle第五条企业应当建立符合药品质量管理要求的质量目标，将药品注册的有关安全、有效和质量可控的所有要求，系统地贯彻到药品生产、控制及产品放行、贮存、发运的全过程中，确保所生产的药品符合预定用途和注册要求。Enterprisesshouldestablishaqualityobjectivewhichmeetsthequalitymanagementrequirements.Accordingtodrugregistration,thesafety,efficacyandqualitycontrolrequirementsshouldbesystematicallyimplementedinthewholeprocessofdrugproduction,qualitycontrol,productrelease,storageandshipmenttoensurethattheproductmeettheintendeduseandregistrationrequirements.第六条企业高层管理人员应当确保实现既定的质量目标，不同层次的人员以及供应商、经销商应当共同参与并承担各自的责任。Article6:Topmanagementpersonnelshouldensuretheestablishedqualityobjectivesachieved,differentlevelsofstaffandsuppliers,distributorsshouldworktogethertoparticipateinandassumetheirresponsibilities.第七条企业应当配备足够的、符合要求的人员、厂房、设施和设备，为实现质量目标提供必要的条件。Enterprisesshouldbeequippedwithadequate,qualifiedstaff,plant,facilitiesandequipmenttoachievequalityobjectivestoprovidethenecessaryconditions.第二节质量保证Section2QualityAssurance第八条质量保证是质量管理体系的一部分。企业必须建立质量保证系统，同时建立完整的文件体系，以保证系统有效运行。Qualityassuranceispartofthequalitymanagementsystem.Enterprisesmustestablishaqualityassurancesystem,whilebuildingacompletedocumentationsystemtoensuretheeffectiveoperationofthesystem.第九条质量保证系统应当确保：Thesystemofqualityassurancesystemshouldensurethat:（一）药品的设计与研发体现本规范的要求；PharmaceuticalproductsaredesignedanddevelopedinawaythattakesaccountoftherequirementofGMP.（二）生产管理和质量控制活动符合本规范的要求；ActivitiesofproductionandqualitycontrolcomplywiththerequirementofGMP.（三）管理职责明确；Managerialresponsibilitiesareclearlyspecifiedinjobdescription;（四）采购和使用的原辅料和包装材料正确无误；Arrangementsaremadeforthemanufacture,supplyanduseofthecorrectstartingandpackagingmaterials.（五）中间产品得到有效控制；Allnecessarycontrolsonintermediateproductsandbulkproductsandotherin-processcontrolsarecarriedout.（六）确认、验证的实施；Qualificationandvalidationsarecarriedout.（七）严格按照规程进行生产、检查、检验和复核；Theproductiscorrectlyproceed,checkedandtested,accordingtothedefinedprocedures.（八）每批产品经质量受权人批准后方可放行；Pharmaceuticalproductsshouldbeapprovedbyqualifiedpersonpriortobereleased.（九）在贮存、发运和随后的各种操作过程中有保证药品质量的适当措施；Satisfactoryarrangementexisttoensurethatthepharmaceuticalproductsarestoredbythemanufacturer,distributed,andsubsequentlyhandledsothatqualityismaintainedthroughouttheirshelf-life.（十）按照自检操作规程，定期检查评估质量保证系统的有效性和适用性。Thereisaprocedureforself-inspectionthatregularlyappraisestheeffectivenessandapplicabilityofthequalityassurancesystem.第十条药品生产质量管理的基本要求：Thebasicrequirementofproductionandqualitymanagement:（一）制定生产工艺，系统地回顾并证明其可持续稳定地生产出符合要求的产品；Allmanufacturingprocessesareclearlydefined,systematicallyreviewedinthelightofexperienceandshowntobecapableofconsistentlymanufacturingmedicinalproductsoftherequiredqualityandcomplyingwiththeirspecifications;（二）生产工艺及其重大变更均经过验证；Criticalstepsofmanufacturingprocessesandsignificantchangestotheprocessarevalidated;（三）配备所需的资源，至少包括：AllnecessaryfacilitiesforGMPareprovidedincluding:1.具有适当的资质并经培训合格的人员；Appropriatelyqualifiedandtrainedpersonnel;2.足够的厂房和空间；Adequatepremisesandspace;3.适用的设备和维修保障；Suitableequipmentandservices;4.正确的原辅料、包装材料和标签；Correctmaterials,containersandlabels;5.经批准的工艺规程和操作规程；Approvedproceduresandinstructions;6.适当的贮运条件。Suitablestorageandtransport;（四）应当使用准确、易懂的语言制定操作规程；Instructionsandproceduresarewritteninaninstructionalforminclearandunambiguouslanguage,specificallyapplicabletothefacilitiesprovided;（五）操作人员经过培训，能够按照操作规程正确操作；Operatorsaretrainedtocarryoutprocedurescorrectly;（六）生产全过程应当有记录，偏差均经过调查并记录；Recordsaremade,manuallyand/orbyrecordinginstruments,duringmanufacturewhichdemonstratethatallthestepsrequiredbythedefinedproceduresandinstructionswereinfacttakenandthatthequantityandqualityoftheproductwasasexpected.Anysignificantdeviationsarefullyrecordedandinvestigated;（七）批记录和发运记录应当能够追溯批产品的完整历史，并妥善保存、便于查阅；Recordsofmanufactureincludingdistributionwhichenablethecompletehistoryofabatchtobetraced,areretainedinacomprehensibleanda