【7A文】英文GMP培训.ppt

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1、GoodManufacturingPracticesDarEsSalaam,TanzaniaAugust2006DrAJvanZylforQualityAssuranceandSafety:MedicinesMedicinesPolicyandStandardsHealthTechnologyandPharmaceuticalsClusterWorldHealthOrganizationProgramGoodManufacturingPracticesPresentationonGMP(Productionfocus)ProductspecificfocusGrou

2、psessionPresentationonGMP(QCfocus)ProductspecificfocusGroupsessionGuidelinesandreferencesGMP:WorldHealthOrganizationWHOTechnicalReportSeries,No.908,2003,Annex4.GoodManufacturingPracticesforpharmaceuticalproducts:mainprinciplesWHOTechnicalReportSeries,No.917,Annex3.WaterWHOTechnicalRepo

3、rtSeries,No.937HVACandothers(2006)GoodManufacturingPractices(GMP)1.Qualityassurance2.Goodmanufacturingpracticesforpharmaceuticalproducts(GMP)3.Sanitationandhygiene4.Qualificationandvalidation5.Complaints6.Productrecalls7.ContractproductionandanalysisGeneralThecontractgiverThecontractac

4、cepterThecontractGoodManufacturingPractices(GMP)8.Self-inspectionandqualityauditsItemsforself-inspectionSelf-inspectionteamFrequencyofself-inspectionSelf-inspectionreportFollow-upactionQualityauditSuppliers’auditsandapproval9.PersonnelGeneralKeypersonnelGoodManufacturingPractices(GMP)1

5、0.Training11.Personalhygiene12.PremisesGeneralAncillaryareasStorageareasWeighingareasProductionareasQualitycontrolareasGoodManufacturingPractices(GMP)13.Equipment14.MaterialsGeneralStartingmaterialsPackagingmaterialsIntermediateandbulkproductsFinishedproductsRejected,recovered,reproces

6、sedandreworkedmaterialsRecalledproductsReturnedgoodsReagentsandculturemediaReferencestandardsWastematerialsMiscellaneous15.DocumentationGeneralDocumentsrequiredGoodManufacturingPractices(GMP)16.GoodpracticesinproductionGeneralPreventionofcross-contaminationandbacterialcontaminationduri

7、ngproductionProcessingoperationsPackagingoperations17.GoodpracticesinqualitycontrolControlofstartingmaterialsandintermediate,bulkandfinishedproductsTestrequirementsBatchrecordreviewStabilitystudiesGoodManufacturingPractices(GMP)ProductionUtilitiesEquipmentDosageformanddataverificatio