扬子江药业集团江苏海慈生物药业有限公司

VENDORQUESTIONNAIREMaterialfromContractor:UP302SectionA:ContractorSiteCompanyName:YangtzeRiverPharmaceutialGroupJiangsuHAI-CIBiologicalPharmaceuticalCo.,Ltd.Address:No.8TaizhenRoad,BinjiangIndustrialPark,EconomicDevelopmentZone,Taizhou,Jiangsu.Telephone:[phone]Fax:[phone]Email:[e-mail]:ManufacturingSite(mustcompletethissectioniftheactualMFGsiteaddressisnotthesameasabove)CompanyName:Address:Telephone:[phone]Fax:Email:[e-mail]:Organization(Note:mustbetheinfooftheactualMFGsite)1.Numberofemployees:QualityAssurance(QA)5QualityControl(QC)25Manufacturing102Sales/Admin2Other90Total2242.ListKeyManufacture,QC/QA,andSalesdepartmentNameTitleContactChenYuanlongMinisterofmanufacturedepartmentTel:86-523-86975600Email:[e-mail]-ministerofmanufacturedepartmentTel:86-523-86976696Email:[e-mail]-ministerofqualityassurancedepartmentTel:86-523-86975630Email:[e-mail]ualitycontroldepartmentTel:86-523-86975632Email:[e-mail]salesdepartmentTel:86-523-86983550Email:[e-mail]:RegulatoryStatus(mustbetheactualMFGSite)1.IsthemanufacturingsiteregisteredwithUSFDA?Yes■NoIfso,whichFDAbranch?:2.WhenwasitlastinspectedbyFDA?NoPleaseattachacopyofyourmostrecent483.3.IsitISOcertified?■YesNoTypeofcertification?_BSOHSAS18001:2007ISO14001:2004_WhoisyourRegistrar?TÜVRheinlandCertGmbH_WhenwasthelastISOaudit?14th-16th,March,2011_4.Arethereotherregulatoryagenciesthatinspectit■YesNoIfso,Pleaselisttheagencies,typeofinspectionanddate:SinhuiHKInternationalTradingCo.,Limitted2011.02SectionD:ProductrelatedInformation(mustbetheactualMFGsite)1.Pleaseattachspecificationsofallstartingmaterialsandintermediates:1-(2,4-dihydroxyphenyl)-ethanone,2,4-dimethoxy-3-methylbenzaldehyde,1-(2,4-bis(benzyloxy)phenyl)ethanone,(E)-1-(2,4-bis(benzyloxy)phenyl)-3-(2,4-dimethoxy-3-methylphenyl)-prop-2-en-1-one,1-(2,4-dihydroxyphenyl)-3-(2,4-dimethoxy-3-methylphenyl)propan-1-one2.Istheproductmanufacturedbyyourcompanyfromstartingmaterialtofinalproduct?Yes■NoIfnot,listthematerialsmadebysub-contractor1-(2,4-dihydroxyphenyl)ethanone(BeijingHWRKChem.Co.,Ltd);2,4-dimethoxy-3-methylbenzaldehyde(3wayPharmInc.)3.ListyourprimaryfacilitywheretheproductismanufacturedReactor:500L,1000L,1500L,2000L,4000L,8000L.Changzhou_deersongPressurevesselCo.,Ltd.Autoclave:GXH-2L.WeihaiHongxieChemicalMachinaryCo.,Ltd.;20L.WeihaiKunchangChemicalMachinaryCo.,Ltd.4.Doyourepackageorre-labeltheproduct?..Yes■NoSectionE:Facilities(mustbetheactualMFGsite)1.Ageofthefacilities3yearsNumberofbuildings15Totalsq.meter_40000m2PleaseattachdescriptionofgeneralhousekeepingprograminthewarehouseandmanufacturingareasandreferenceyourSOPnumbers.A:Procedureofmaterialreleaseinthewarehouse(SOP-MM-00003):1.Basicprinciple;2.Deliveryofmaterial2.1Materialpreparation;2.2Materialrelease;2.3Disposalofnonconformingmaterial;2.4Registeringandfiling.B:Receptionanddeliveryoffinished-productsinthewarehouse(SOP-MM-00006):1.Receptionoffinished-products1.1Checking;1.2Numbering;1.3Statemanagement;1.3.1Finished-productswaitingforexamination;1.3.2Disposalofconformingfinished-products;1.3.3Disposalofnonconformingfinished-products;2.Storageoffinished-products;3.Deliveryoffinished-products3.1Basicprinciples;3.2Deliveryoffinished-productsonsale;4.Managementoffinished-productswithintheirsvalidityperiod;5.Disposalofreturnedproducts;6.Registeringandfiling.2.Mayweconductaphysicalauditofyourfacility?■YesNoSectionF:Rawmaterials1.Pleaseattachlistofrawmaterialsincludingthechemicalreagentsyouusetomanufacturethisproduct:2,4-dihydroxyacetophenone,benzylchloride,2,4-dimethoxy-3-methylbenzaldehye,potassiumcarbonate,sodiumbicarbonate,sodiumsulfate,potassiumhydroxide,concentr-atedHCl(36%),aceticacid,10%Pd/C,formicacid,H2,Vitride(70%intoluene),Charcoal.2.Rawmaterialrelatedquestionsa.PleaseattachdescriptionofyouridentificationprocedureforrawmaterialsEstablishtheirownqualitystandardsforallrawmaterials,andcheckwhetherthequalityofthematerialswouldbeinaccordwiththestandards.b.Doyouretainordepositrawmaterials?■YesNoSectionG:Manufacture(mustbetheactualMFGsite)1.Areotherproductsmanufacturedinthesamearea?YesNo2.PleaselistmajorchemicalorpharmaceuticalsmadeatthesameMFGsite:3.Whatpreventativemeasuresareinplacetopreventcrosscontamination?Atoneoperatingroom,justthepackageofthesamebatchofthesameproductisallowed.4.Whatisyourprocedurefornotifyingyourcustomersofanyproposedchangesinthemanufacture,sourceofmaterials,testing,specification,packagingorfacilitylocationfortheproductionofthisrawmaterial?Ifthereareanychangesineachlinkofproduction,wewouldevaluatewhetherthequalityofproductscouldbeassured,andthenprovidethefileonthechangesinlinkofproductiontoourcustomers.5.Doeseverylotofmaterialhaveabatchrecord?■YesNo6.Areequipmentmaintenanceorservicerecordsavailable?.■YesNo7.PleaseattachdescriptionofcalibrationprogramforequipmentusedinthemanufacturingprocessforthisproductandreferenceyourSOPnumbers8.Wr