(中英文)附录2 who药品gmp指南

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1、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Qu

2、alityriskmanagement质量风险管理新增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、检验和其他活动修

3、改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

4、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.Material

5、s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Wastemate

6、rials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.Goodpract

7、icesinqualitycontrolQC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)wasprepared

8、in1967byagroupofconsultantsattherequestoftheTwentiethWorldHealthAssembly(resolutionWHA20.34).ItwassubsequentlysubmittedtotheTwenty-firstWorldHeal