Australian Code of Good Manufacturing Practice - Human Blood and Tissues.pdf

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1、AustralianCodeofGoodManufacturingPracticeHumanBloodandTissues24August2000TherapeuticGoodsAdministrationAbouttheTherapeuticGoodsAdministration(TGA)·TheTGAisadivisionoftheAustralianGovernmentDepartmentofHealthandAgeing,andisresponsibleforregulatingmedicinesandmedicaldevices.·TGAadministerstheThe

2、rapeuticGoodsAct1989(theAct),applyingariskmanagementapproachdesignedtoensuretherapeuticgoodssuppliedinAustraliameetacceptablestandardsofquality,safetyandefficacy(performance),whennecessary.·TheworkoftheTGAisbasedonapplyingscientificandclinicalexpertisetodecision-making,toensurethatthebenefitst

3、oconsumersoutweighanyrisksassociatedwiththeuseofmedicinesandmedicaldevices.·TheTGAreliesonthepublic,healthcareprofessionalsandindustrytoreportproblemswithmedicinesormedicaldevices.TGAinvestigatesreportsreceivedbyittodetermineanynecessaryregulatoryaction.·Toreportaproblemwithamedicineormedicald

4、evice,pleaseseetheinformationontheTGAwebsite.Copyright©CommonwealthofAustralia2000Thisworkiscopyright.ApartfromanyuseaspermittedundertheCopyrightAct1968,nopartmaybereproducedbyanyprocesswithoutpriorwrittenpermissionfromtheCommonwealth.Requestsandinquiriesconcerningreproductionandrightsshouldbe

5、addressedtotheCommonwealthCopyrightAdministration,AttorneyGeneral’sDepartment,NationalCircuit,BartonACT2600orpostedathttp://www.ag.gov.au/ccaAustralianCodeofGoodManufacturingPractice-HumanPageiBloodandTissues,August2000TABLEOFCONTENTSPAGEPREFACEivINTRODUCTIONivKEYINTERPRETATIONSFROMTHEACTviREF

6、ERENCES31GLOSSARY32-35INDEX36-41SECTIONCLAUSES1.QUALITYSYSTEMRationale100General101-103QualityObjectives104OrganisationalStructure·General105-106·Director107·QAandProductionNominees108-112·ResourcesandPersonnel113QualitySystemrequirements·Documentation114-115·ChangeControl116MonitoringSystems·

7、General117·InternalAudit118-120·CorrectiveAction121-122ManagementReview123-1252.PERSONNELANDTRAININGRationale200General201-206Training207-212Records213-2153.BUILDINGSANDFACILITIESRationale300General301-304EnvironmentalControl305-308Floo