韩国原料药注册文件

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1、QuestionnaireforSuppliersQuestionnaireforSuppliersNameofCompany:Witten&Approval(점검표의작성및승인)Division(구분)Duty(직책)Name(성명)Signature(서명)Date(일자)Writtenby(작성자)Approvedby(승인자)Auditor(평가업체)Division(구분)Name(성명)Signature(서명)Date(일자)Confirmedby(확인자)QualityAssurenceteamleader(품질보증팀장)Qual

2、ityControlmanager(품질부서책임자)_______________________________________________________________________________________________________________________________________________QuestionnaireforSuppliersTableofContent1.GeneralInformation(일반현황)32.Personnel(직원)53.Manufactoryandequipment(제조소

3、및설비)54.Production(생산)65.Packaging(포장)76.Storage&Shipping(보관및운송)77.Qualitymanagement(품질경영)88.QualityAssurance(품질보증)99.QualityControl(품질관리)1110.Validation(밸리데이션)1211.ProcessValidation(공정밸리데이션)1312.CleaningValidation(세척밸리데이션)1413.SupportSystemValidation(제조지원설비밸리데이션)1414.AnalyticalMe

4、thodValidation(분석법밸리데이션)1415.ComputerSystemValidation(컴퓨터시스템밸리데이션)1516.Contractmanufactureandanalysis(위탁생산및분석)1517.Riskmanagement(위험관리)1518.DocumentationandRecords(문서와기록)1619.HerbalPharmaceuticalProductionArea(한약(생약)제제작업소)17Appendix1.RequestedData21_______________________________

5、________________________________________________________________________________________________________________QuestionnaireforSuppliers1.GeneralInformation(일반현황)Supplier(공급업체)Manufacturer’sname(제조사)Representative(대표자)Location(소재지)Website(인터넷주소)PhoneNo.(전화번호)FaxNo.(팩스번호)Manufact

6、uringManager(제조부서책임자)QualityUnitManager(품질부서책임자)NameofProductstobesupplied(공급품목명)Contactperson(담당자)Name(이름)Duty직책)PhoneNo.(전화번호)FaxNo.(팩스번호)E-mail(이메일주소)Requestdocuments(Ifyouhavedatapleasemarkonit)No.CheckItem(항목)Result(O,X)AttachedDocumentNumber(첨부문서번호)1GMPcertificates.(GMP인증서)

7、2ISOcertificates(9001or14001)(ISO증명서)3Organizationalchart(조직도)4Alayoutdiagramofthefacility(시설배치도)5SOPindex(SOP목록)6Sitemasterfile(ifyouhave)(제조소총람)7SupplyMaterialList(원료공급목록)noteIfdon’tattachrequesteddocuments,pleaseexplainthereason.:_______________________________________________

8、________________________________________