VENDORQUESTIONNAIREMaterialfromContractor:UP302SectionA:ContractorSiteCompanyName:YangtzeRiverPharmaceutialGroupJiangsuHAI-CIBiologicalPharmaceuticalCo.,Ltd.Address:No.8TaizhenRoad,BinjiangIndustrialPark,EconomicDevelopmentZone,Taizhou,Jiangsu.Telephone:86-523-86976637Fax:86-523-86976640Email:chemime@163.comSectionA:ManufacturingSite(mustcompletethissectioniftheactualMFGsiteaddressisnotthesameasabove)CompanyName:Address:Telephone:86-523-86975600Fax:Email:chenyl@yangzijiang.comSectionB:Organization(Note:mustbetheinfooftheactualMFGsite)1.Numberofemployees:QualityAssurance(QA)5QualityControl(QC)25Manufacturing102Sales/Admin2Other90Total2242.ListKeyManufacture,QC/QA,andSalesdepartmentNameTitleContactChenYuanlongMinisterofmanufacturedepartmentTel:86-523-86975600Email:chenyl@yangzijiang.comZhuShenghongVice-ministerofmanufacturedepartmentTel:86-523-86976696Email:zsh@yangzijiang.comLuLinVice-ministerofqualityassurancedepartmentTel:86-523-86975630Email:lulin_0706@yahoo.com.cnJiangxueqinDirectorofqualitycontroldepartmentTel:86-523-86975632Email:jxq@yangzijiang.comZhaoJinfangDirectorofsalesdepartmentTel:86-523-86983550Email:zhaojinfang@126.comSectionC:RegulatoryStatus(mustbetheactualMFGSite)1.IsthemanufacturingsiteregisteredwithUSFDA?Yes■NoIfso,whichFDAbranch?:2.WhenwasitlastinspectedbyFDA?NoPleaseattachacopyofyourmostrecent483.3.IsitISOcertified?■YesNoTypeofcertification?_BSOHSAS18001:2007ISO14001:2004_WhoisyourRegistrar?TÜVRheinlandCertGmbH_WhenwasthelastISOaudit?14th-16th,March,2011_4.Arethereotherregulatoryagenciesthatinspectit■YesNoIfso,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;3.2Deliveryoff...
