【6A文】英文GMP培训.ppt

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1、GoodManufacturingPracticesDarEsSalaam,TanzaniaAugust2006DrAJvanZylforQualityAssuranceandSafety:MedicinesMedicinesPolicyandStandardsHealthTechnologyandPharmaceuticalsClusterWorldHealthOrganizationProgramGoodManufacturingPracticesPresentationonGMP(Productionfocus)ProductspecificfocusGroupsessionPrese

2、ntationonGMP(QCfocus)ProductspecificfocusGroupsessionGuidelinesandreferencesGMP:WorldHealthOrganizationWHOTechnicalReportSeries,No.908,2003,Annex4.GoodManufacturingPracticesforpharmaceuticalproducts:mainprinciplesWHOTechnicalReportSeries,No.917,Annex3.WaterWHOTechnicalReportSeries,No.937HVACandothe

3、rs(2006)GoodManufacturingPractices(GMP)1.Qualityassurance2.Goodmanufacturingpracticesforpharmaceuticalproducts(GMP)3.Sanitationandhygiene4.Qualificationandvalidation5.Complaints6.Productrecalls7.ContractproductionandanalysisGeneralThecontractgiverThecontractaccepterThecontractGoodManufacturingPract

4、ices(GMP)8.Self-inspectionandqualityauditsItemsforself-inspectionSelf-inspectionteamFrequencyofself-inspectionSelf-inspectionreportFollow-upactionQualityauditSuppliers’auditsandapproval9.PersonnelGeneralKeypersonnelGoodManufacturingPractices(GMP)10.Training11.Personalhygiene12.PremisesGeneralAncill

5、aryareasStorageareasWeighingareasProductionareasQualitycontrolareasGoodManufacturingPractices(GMP)13.Equipment14.MaterialsGeneralStartingmaterialsPackagingmaterialsIntermediateandbulkproductsFinishedproductsRejected,recovered,reprocessedandreworkedmaterialsRecalledproductsReturnedgoodsReagentsandcu

6、lturemediaReferencestandardsWastematerialsMiscellaneous15.DocumentationGeneralDocumentsrequiredGoodManufacturingPractices(GMP)16.GoodpracticesinproductionGeneralPreventionofcross-contaminationandbacterialcontaminationduringproductionProcessingoperationsPackagingoperations17.Goodpracticesinqualityco

7、ntrolControlofstartingmaterialsandintermediate,bulkandfinishedproductsTestrequirementsBatchrecordreviewStabilitystudiesGoodManufacturingPractices(GMP)ProductionUtilitiesEquipmentDosageformanddataverificatio