APIC指南：How+to+do+document+version+6+Feb+2010

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1、ACTIVEPHARMACEUTICALINGREDIENTSCOMMITTEEGMPsforAPIs:“Howtodo”DocumentInterpretationoftheICHQ7aGuideVersion6Cefic/APIC"Howtodo"-DocumentPage2of69TableofContents(RevisedchaptersinthisVersionarehighlightedinblue)1Introduction2QualityManagement3Personnel4BuildingsandFacilities5Proce

2、ssEquipment6DocumentationandRecords7MaterialsManagement8ProductionandIn-ProcessControls9PackagingandIdentificationLabellingofAPIsandIntermediates10StorageandDistribution11LaboratoryControls12Validation13ChangeControl14RejectionandReuseofMaterials15ComplaintsandRecalls16ContractM

3、anufacturers(includingLaboratories)17Agents,Brokers,Traders,Distributors,Repackers,andRelabellers18SpecificGuidanceforAPIsManufacturedbyCellCulture/Fermentation19APIsforUseinClinicalTrials20Glossary(pleaserefertotheoriginalQ7a-guidelineforanydefinitions)Howtodo-ICHQ7a_Feb2010.do

4、cxVersion6Cefic/APIC"Howtodo"-DocumentPage3of69Chapter1Introduction1.1ObjectiveHistoricalBackgroundWhentheinitiativewastakenbyPIC/SattheCanberrameetinginSeptember1996todraftagloballyharmonisedGoodManufacturingPractices(GMP)guidefortheProductionofActivePharmaceuticalIngredients(A

5、PI‟s),therecommendationwasmadethatthisshouldessentiallybea“whattodo”,ratherthana“howtodo”docu-ment.AfterthatinitiativetheInternationalConferenceonHarmonisation(ICH),whichconsistsofthethreemajorpharmaceuticalregionsoftheworld-USA,JapanandEurope-tookthetopiconboard.TheICHestablish

6、edanExpertWorkingGroup(EWG)whichmembershipwasduetotheimportanceofthetopicextendedbeyondthethreeregionstoWHO,PIC/Smembers,India,ChinaandOTCandGenericin-dustryrepresentatives.TheEWG,ofwhichCEFICAPICwasamemberof,hascompiledthe'GMPsforAPIs'Guidewithin2½yearstime.Thedocumentwasfinali

7、sedbyNovember2000andisnowatthestagetobeimplementedwithinthethreeregions.PurposeoftheDocumentThisdocumentwaswrittenbyexpertsfromtheEuropeanIndustry(CEFICAPIC).Itisessentiallyaninterpretationof“howto”implementtheICHQ7aGuidebasedonpracticalexperience.Otherrelevantpublications(e.g.I

8、SPEBaselineGuides,otherICHGuidelines)weretakeni