(中英文)附录2 WHO药品GMP指南

Annex2WHOgoodmanufacturingpracticesforpharmaceuticalproducts:mainprinciples附录2WHO药品GMP：主要原则Introduction引言Generalconsiderations总则Glossary术语Qualitymanagementinthemedicinesindustry:philosophyandessentialelements制药企业的质量管理：GMP理念和基本元素1.Pharmaceuticalqualitysystem制药质量体系Qualityriskmanagement质量风险管理Productqualityreview产品质量回顾2.Goodmanufacturingpracticesforpharmaceuticalproducts药品GMP3.Sanitationandhygiene清洁和卫生4.Qualificationandvalidation确认和验证5.Complaints投诉6.Productrecalls产品召回7.Contractproduction,analysisandotheractivities委托生产、检验和其他活动General概述Thecontractgiver委托方Thecontractaccepter被委托方Thecontract合同8.Self-inspection,qualityauditsandsupplier’sauditsandapproval自检、质量审计、供应商审计和批准Itemsforself-inspection自检项目Self-inspectionteam自检团队Frequencyofself-inspection自检频率Self-inspectionreport自检报告Follow-upaction后续措施Qualityaudit质量审计Suppliers’auditsandapproval供应商审计和批准9.Personnel人员General概述Keypersonnel关键人员10.Training培训11.Personalhygiene人员卫生12.Premises厂房General概述Ancillaryareas辅助区域Storageareas仓储区域Weighingareas称量区域Productionareas生产区域QualitycontrolareasQC区域13.Equipment设备14.Materials物料General概述Startingmaterials起始物料Packagingmaterials包装材料Intermediateandbulkproducts中间体和成品Finishedproducts制剂Rejected,recovered,reprocessedandreworkedmaterials不合格、回收、返工和重加工物料Recalledproducts召回产品Returnedgoods退货Reagentsandculturemedia试剂和培养基Referencestandards标准品Wastematerials废弃物料Miscellaneous其他15.Documentation文件General概述Documentsrequired需要的文件16.Goodpracticesinproduction生产良好规范General概述Preventionofcross-contaminationandbacterialcontaminationduringproduction生产过程中交叉污染和额细菌污染的预防Processingoperations生产操作Packagingoperations包装操作17.GoodpracticesinqualitycontrolQC良好规范Controlofstartingmaterialsandintermediate,bulkandfinishedproducts原材料、关键中间体、原料药和制剂的控制Testrequirements检测要求Batchrecordreview批记录审核Stabilitystudies稳定性研究References参考文献Introduction引言ThefirstWHOdrafttextongoodmanufacturingpractices(GMP)waspreparedin1967byagroupofconsultantsattherequestoftheTwentiethWorldHealthAssembly(resolutionWHA20.34).ItwassubsequentlysubmittedtotheTwenty-firstWorldHealthAssemblyunderthetitle“Draftrequirementsforgoodmanufacturingpracticeinthemanufactureandqualitycontrolofmedicinesandpharmaceuticalspecialities”andwasaccepted.应第二十届世界卫生大会（大会决议WHA20.34）的要求，1967年由一顾问小组起草了WHO首版GMP草案。随后，以“药品和药学类的生产和质量控制的GMP草案要求”为题提交到第二十一届世界卫生大会并通过。TherevisedtextwasdiscussedbytheWHOExpertCommitteeonSpecificationsforPharmaceuticalPreparationsin1968andpublishedasanannextoitstwenty-secondreport.Thetextwasthenreproduced(withsomerevisions)in1971intheSupplementtothesecondeditionof“TheInternationalPharmacopoeia”.1968年，WHO药品规范专家委员对修订的版本进行了讨论，并将其作为该委员会第22次报告附录出版。1971年，文档被复制后（有一些修订）作为国际药典第二版的补充内容出现。In1969,whentheWorldHealthAssemblyrecommendedthefirstversionoftheWHOCertificationSchemeontheQualityofPharmaceuticalProductsMovinginInternationalCommerceinresolutionWHA22.50,itacceptedatthesametimetheGMPtextasanintegralpartoftheScheme.RevisedversionsofboththeCertificationSchemeandtheGMPtextwereadoptedin1975byresolutionWHA28.65.Sincethen,theCertificationSchemehasbeenextendedtoincludethecertificationof:—veterinaryproductsadministeredtofood-producinganimals;—startingmaterialsforuseindosageforms,whentheyaresubjecttocontrolbylegislationinboththeexportingMemberStateandtheimportingMemberState;—informationonsafetyandefficacy(resolutionWHA41.18,1988).1969年，世界卫生大会在大会决议（WHA22.50）中形成第一版国际贸易的WHO药品质量认证计划，并在当时接受GMP文档作为计划的一部分。在1975年，决议WHA28.65采用了修订后的认证体制和GMP文档。从那时起，认证计划已扩展到包括以下内容的认证：——可食用动物所用兽药——进出口成员国有关法规控制的药品所用的起始物料。——证明药品安全性和有效性的资料（决议WHA41.18，1998）In1992,thereviseddraftrequirementsforGMPwerepresentedinthreeparts,ofwhichonlyPartsOneandTwoarereproducedinthisdocument(1).1992年，修订后的GMP草案要求分为三个部分，其中只有1和2部分引入此文档中。“Qualitymanagementinthemedicinesindustry:philosophyandessentialelements”,outlinesthegeneralconceptsofqualityassurance(QA)aswellastheprincipalcomponentsorsubsystemsofGMP,whicharejointresponsibilitiesoftopmanagementandofproductionandqualitycontrolmanagement.Theseincludehygiene,validation,self-inspection,personnel,premises,equipment,materialsanddocumentation.“制药企业的质量管理：GMP理念和基本要素”概述了质量保证和GMP主要要素或体系的基本概念，这是企业最高管理层以及生产和质量控制部门的共同职责。包括卫生、验证、自检、人员、厂房、设备、物料和文件等内容。“Goodpracticesinproductionandqualitycontrol”,providesguidanceonactionstobetakenseparatelybyproductionandbyqualitycontrolpersonnelfortheimplementationofthegeneralprinciplesofQA.“生产和质量良好规范”分别为生产和质量控制人员的具体操作提供了指南，以实现质量保证的基本总则。ThesetwopartsweresubsequentlysupplementedbyfurtherguidelineswhichareintegralpartsoftheseGMPforpharmaceuticalproducts.AllthesetextsareavailableontheMedicineswebpage(http.).这两部分随后通过药品GMP指南不可缺少的一部分内容进一步补充，这些内容可在药品网站上查到：(http.).ConsiderabledevelopmentsinGMPhavetakenplaceintheinterveningyears,andimportantnationalandinternationaldocuments,includingnewrevisions,haveappeared(2-5).Thusthereisanecessitytorevisethemainprinciplesandincorporatetheconceptofvalidation.这些年来，GMP领域取得很大的发展，重要的国家和国际文件已经出现，包括新修订的（2-5）。因此有必要修订主要原则和合并验证概念。Amongotheritemsoff