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制药类企业供货商问卷调查QUESTIONNAIREFORSUPPLIERSOFACTIVEORINACTIVEPHARMACEUTICALINGREDIENTS(활성또는비활성원료의약품공급회사용점검표)Supplier(공급사)供货商Nameofvendorcompany:卖方国家(회사명)Address:地址(주소)Country:国家(국가)PhoneNo.:电话FaxNo.:传真(전화번호)(팩스번호)Concernedproducts(관련제품)联系产品Nameofcontactperson:联系人Title:职位(담당자)(직위)PhoneNo.:电话FaxNo.:传真(전화번호)(팩스번호)E-mailaddressofcontactperson:联系人邮箱地址(담당자이메일주소)Buyer(구매자)买方Date(일자)日期..Confirmedby(확인자)确定日期QualityAssurenceteamleader(품질보증팀장)质检组领导QualityControlmanager(품질부서책임자)质量控制经理1.GeneralInformation(기본정보)No.항목YESNODescriptions1.1Whattypeofproductsdoyoumanufacture?贵司生产何种产品？(어떤종류의제품을생산하십니까?)PlantExtracts，Foodadditive，Feedadditive，ChemicalIntermediate植物提取物，食品添加剂，饲料添加剂，化学溶媒1.2Areanyofthefollowingmaterialsproducedatthesamesiteasmaterialstobe/beingpurchased我们所购产品的生产场地是否同时生产如下产品：(아래물질들중에서구매가능한물질로동일지역에서생산되는물질이있습니까?)a.Antibiotics(항생제)抗生素Nob.Pesticides/herbicides(살충제/제초제)杀虫剂、除草剂Noc.Biologicals(생물학적제제)生物制剂Nod.Steroids(스테로이드)激素类Noe.Cytotoxics(세포독성물질)细胞毒素Nof.Highlyactivematerials(고활성물질)高活跃性原料No1.3Howiscross-contaminationavoided(controlled)?交叉污染如何避免(어떻게교차오염을방지(통제)하시는지요?)Productprotectiontraining,partitionstorage,sanitationandcleaningtraining,1.4Isthecompanyadivisionorsubsidiaryoraffiliateofanothercorporation?此公司是否为分公司，子公司或者隶属其他集团(회사가다른기업의부서이거나자회사또는계열사입니까?)NO1.5Proportionofcustomertype厂家类型(귀사고객비율)a.Pharmaceuticals(제약)制药(57)%b.Foods(식품)食品(28)%c.Cosmetics(화장품)化妆品(10)%d.Other(기타)其他(5)%2.Personnel(직원)人员情况No.항목YESNODescriptions2.1Numberofstaff:(직원수)员工数量a.Staffinproduction(생산직원)生产工人57b.Staffinqualityassurance(QA)(품질보증팀직원)质检工人7c.Staffinqualitycontrol(QC)(품질관리팀직원)质控工人11d.StaffinR&D(연구개발직원)研发人员122.2Howmanyemployeesworkatyourfacility?厂区雇员人数설에서근무하는직원은몇명입니까?)a.Fulltime(정규직)全职87b.Parttime(시간제)兼职0No.항목YESNODescriptionsc.Temporary(임시직)临时02.3Aretheytrained?(직원들은교육을받습니까?)是否经过培训Yes2.4DoyouhavewrittentrainingprogramforproductionandQA/QCpersonnel?(생산직과QA/QC직원을위한교육프로그램이문서로되어있습니까?)是否有写生产以及质检、质控员工计划。a.Fornewemployees(신규직원용)新员工Yesb.Forcurrentemployees(기존직원용)现有员工Yes2.5Doesyourtrainingprogramincludethefollowings?贵司员工培训计划是否包括如下事宜：(교육프로그램은아래의내용을포함하고있습니까?)a.GMPprinciples(GMP원리)GMP认证Yesb.Jobtraining(직무교육)工作技能训练Yesc.Safetyandenvironmentalissues(안전및환경)安全与环保Yesd.ISOprinciples(ISO원리)ISO培训NO2.6Isefficiencyoftrainingregularlychecked?培训效果是否经常被检验으로점검하십니까?)a.Byexamination(시험)通过考试Yesb.Byanyanotherway(다른방법)通过其他方式NOc.Ifyes,whatisthefrequency?如有，检测频率是多久一次(예라면얼마나자주하십니까?)Halfyear2.7Aretrainingprogramrecordsmaintainedforallemployees?培训计划是否针对所有员工Yes2.8Istherewrittenjobdescriptionforallemployers?是否有员工工作记录무기술서가쓰여져있습니까?)Yes2.9Doesjobdescriptionincludethedeputyship?工作记录是否包括代理이포함되어있습니까?)Yes2.10Ismedicalcheckforworkersobligatory,regularanddocumented?是否员工被要求进行体检，有常规体检，以及有文件记录？(직원의건강진단이의무적,정기적으로시행되며문서화되어있습니까?)Yes3.Facilities(시설)设施No.항목YESNODescriptions3.1Dependingonconcernedproducts:与产品相关的设施a.Sizeofproductionarea:生产区域2100squaremetreb.Sizeofwarehouses:仓储区域800squaremetrec.SizeofR&D研发区域230squaremetreNo.항목YESNODescriptionsd.Ageofbuildings:建筑物年限15yearse.Numberofbuildings:(건물의수)建筑物数量4f.Type(Single/Multi-Story,Wood/Brick/Block/Steel)房屋类型（单层/多层，木制/砖制/混凝土/钢铁）(건물유형–단층/복층및목재/벽돌/블록/강철)Multi-Story，Brick，Steel3.2Isthereafacilities(아래의시설이있습니까?)是否有如下设施a.R&DLab(R&D실험실)研发实验室Yesb.QCLab(QC실험실)质控实验室Yesc.MicrobiologicalLab(미생물실험실)微生物实验室Yesd.PilotPlant(파일럿작업실)实验用植物在中Yes3.3Istherewrittendocumentedinsectandrodentcontrolprogram?是否有昆虫及啮齿类动物控制记录(방충방서프로그램은문서화되어있습니까?)Yes4.Premisesandequipment(제조소및설비)No.항목YESNODescriptions4.1Aretherewrittenqualificationprocedures(IQ,OQ,PQ)?是否对工人进行（IQ,OQ,PQ）测试Yes4.2Doyouworkwithqualifiedequipment?是否使用高档设备(적합성이검증된장비로작업하십니까?)Yes4.3IsthereaSOPforcleaningtheequipment/room?是否有清洗设备和车间的标准操作程序a.Betweendifferentbatchesofthesameproduct(동일제품의배치와배치사이)不同批次同一产品Yesb.Betweendifferentproducts不同产品Yes4.4Doyouhavevalidatedcleaningproceduretoremovethepreviousproductincaseof是否有有效的清洗程序a.Dedicatedequipment(전용장비)专用设备Yesb.Multipurposeequipment(공용장비)多功能设备Yes4.5Isthereawrittenpreventivemaintenanceprogramforallequipmentusedinproduction?在生产过程中对所有设备是否有预防医学维护程序Yes4.6Aretheappliedmeasuringinstruments(e.g.balances,pressure-gauges,thermometers)calibrated?是否有测量仪器（比如天平、液压测量仪、温度计）等Yes4.7Isthatdocumented?是否有记录Yes5.Production(생산)产品No.항목YESNODescriptions5.1Isthereahygienemonitoringprogramintheproductionarea?(작업장에환경관리프로그램이있습니까?)生产区域是否有卫生监控Yes5.2Isthereseparated(아래구역은분리되어있습니까?)厂区是否是隔离的a.Dressingroom(탈의/갱의실)更衣室Yesb.Cafeteria(구내식당)餐厅Yesc.Smokingplaces(흡연구역)吸烟区Prohibitsmoking5.3Aretheredressinginstructions?是否有衣着要求(갱의지시서가있습니까?)Yes5.4Isthereair-handlingsystemlikeHVAC(Heating,VentilationandAirConditionSystem)?是否有空气调节装置（加热、通风、空调系统）？a.Indispensingarea(소분지역)在配药区NoRawMaterialb.Inproductionarea(생산지역)在生产区Yesc.Infinalprocessingandpackagingrooms(최종공정및포장실)在后期加工及包装区Yes5.5DoyoumanufactureaccordingtoICH7QAguideline?生产是否遵循ICH7QA准则Yes5.6Whichdepartmentreviewsandapprovesmasterproductiondocuments?哪一部门检测产品并提供生产文件(어떤부서에서제품표준서를검토하고승인하시는지요?)QAa.Revisionperiod(개정주기)修订周期2years5.7Doyouusein-processcontrolforallrelevantstageofmanufacturingprocess(IPC)?是否在所有的相关步骤实施质量控制程序Yes5.8Aremanufacturingparametersrecordedonbatchrecords?是否记录每一批次生产参数Yes5.9Whatisyourdefinit