文件名稱/DocumentName文件編號DocumentNo.SMP-09-007-1供應(yīng)商管理規(guī)程Suppliermanagementregulation文件頁碼Page20/20執(zhí)行日期Executivedate2013.06.01頒發(fā)部門IssuedDept.品管部QADept.文件名稱文件編號：GMP文件管理規(guī)程版本號：頁碼：1/20執(zhí)行日期：一、目的（Purpose）為規(guī)范供應(yīng)商的管理，保證供應(yīng)商提供的原料、輔料、包裝材料質(zhì)量穩(wěn)定可靠，符合本公司生產(chǎn)需求，制訂本規(guī)程。Inordertostandardizethemanagementofsuppliers,toensurequalitystableandreliableofrawmaterials,auxiliarymaterials,packagingmaterialswhicharesuppliedbysuppliers,Inaccordancewiththeneedsofthecompany'sproduce,developingthisprocedures.二、適用范圍（Scope）本規(guī)程適用于所有藥品的原料、輔料和包裝材料供應(yīng)商，包括經(jīng)銷商和生產(chǎn)廠家。Theproceduresapplytoallsuppliersofrawmaterials,auxiliarymaterialsandpackaging,includingdistributorsandmanufacturers.三、職責(zé)（Responsibilities）采購部：收集供應(yīng)商信息，與供應(yīng)商進行日常交流，按品管部發(fā)放的合格供應(yīng)商清單采購，配合品管部完成審計工作；對供應(yīng)商的供貨及服務(wù)情況進行再評價。負責(zé)對試劑供應(yīng)商的執(zhí)照確認及采購的工作。PurchasingDepartment:Collectsupplier’sinformation,dailycommunicationwithsuppliers,theorderisaccordedtothelistofqualifiedsuppliersfromQADept,CooperatewithQADept.tocompletetheaudit;Re-evaluatethesupplier'ssupplierandservices;Confirmthelicenseofreagentsupplierandpurchasereagent.品管部：審核供應(yīng)商資質(zhì)，對變更供應(yīng)商的申請進行評估，管理供應(yīng)商檔案，擬定質(zhì)量協(xié)議，關(guān)注供應(yīng)商變更的進度，追蹤進廠物料異常狀況的處理情況，組織并實施現(xiàn)場審計，定期更新合格供應(yīng)商清單，起草供應(yīng)商年度審計計劃和對供應(yīng)商進行定期再評價；QADept.:Auditsupplier’squalification,Assesstherequestofchangingsupplier,managesupplier’sfiles,establishqualityagreement,payattentiontotheprogressofchangesinsuppliers,tracethehandlingofabnormalconditionsoftheIncomingmaterials,organizeandimplementon-siteaudit,regularlyupdatethelistofqualifiedsuppliers,drafttheannualplanofauditandmakearegularassesstosuppliers;物流部：參照品管部發(fā)放的合格供應(yīng)商清單進行入庫驗收。LogisticsDept:AccordingtoQADept.issuedthequalifiedsupplierslistforacceptancecheck生產(chǎn)部：對變更供應(yīng)商的申請進行評估，確定變更后安排車間進行試生產(chǎn)；Production:Assesstherequestofchangingsupplier,ArrangetheWorkshoptoTrial-produceafterdeterminingthechange.技術(shù)部：對變更供應(yīng)商的申請進行評估，按照國內(nèi)法規(guī)要求將新供應(yīng)商報藥監(jiān)部門備案；TechnologyDept.:Assesstherequestofchangingsupplier,declarethenewsuppliertoSFDAinaccordancewiththerequirementofdomesticregulatory.國際注冊部：對變更供應(yīng)商的申請進行評估，按國外相關(guān)法規(guī)要求申報物料供應(yīng)商的清單和進行變更申報；進行注冊申報物料供應(yīng)商的清單及變更；InternationalRegistrationsDept.:Assesstherequestofchangingsupplier,declarethelistofsuppliersinaccordancewiththerequirementofoverseasregulatoryanddeclarethechange.Registerthelistofsuppliersandthechange.化驗室：承擔(dān)供應(yīng)商變更過程中的檢驗及研究驗證工作，參加供應(yīng)商定期再評價，參與對供應(yīng)商的現(xiàn)場審計；QCDept.:Commitmenttochangeintheprocessofinspectionandverificationresearchofsuppliers,participateinperiodicre-evaluationofsuppliers,Participateintheon-siteauditstothesupplier;各生產(chǎn)車間：對變更供應(yīng)商的申請進行評估，承擔(dān)供應(yīng)商變更過程中的試生產(chǎn)工作，參與對供應(yīng)商的現(xiàn)場審計；Theworkshop:Assesstheapplicationofchangingthesupplier,responsiblefortheTrial-produceduringtheprocessofchangingsupplier;participateintheonsuppliersiteaudits;質(zhì)量負責(zé)人：評估并批準變更供應(yīng)商的立項申請，批準、暫?；蚪K止合格供應(yīng)商資格，批準供應(yīng)商年度審計計劃和供應(yīng)商定期再評價表。Responsiblepersonofquality:assessandapprovetheprojectapplicationofchangingsupplier.Approve,suspendorterminatethequalifiedsuppliers,approvetheplanofannualaudittosupplierandtheregularsupplierevaluationform.四、主題內(nèi)容（Subjectcontent）1、物料的分類theclassificationofmaterials我們將物料分為三級，其中：關(guān)鍵物料（A）——對藥品安全性和有效性有影響的物料是關(guān)鍵物料；對質(zhì)量有影響的物料（B）——只影響藥品的某項物理或化學(xué)特性的物料以及標簽和說明書；對質(zhì)量無影響的物料（C）——對最終產(chǎn)品無任何影響的物料。Allmaterialswillbeclassifiedintothreecategories：“criticalmaterial”（A）isrefertothematerialswhichimpactthesafetyandefficacyofdrugs.“materialofinfluencingtheQualityoftheproducts”（B）isrefertolabels,specificationsandthematerialswhichonlyimpactaphysicalorchemicalproperty,“materialofnon-influencingtheQualityoftheproducts”（C）isrefertothematerialswhicharenoanyimpactonthefinalproduct.2、供應(yīng)商的選擇和批準supplierselectionandapproval所有物料的供應(yīng)商必須具備該行業(yè)法定的生產(chǎn)經(jīng)營資質(zhì)；所供產(chǎn)品應(yīng)符合法定要求且需滿足我公司的生產(chǎn)要求；同時我們需要對供應(yīng)商的生產(chǎn)保證體系和質(zhì)量保證體系的有效性和適用性進行評估，確認其能持續(xù)穩(wěn)定地生產(chǎn)和提供符合我公司要求的產(chǎn)品，最終得到質(zhì)量負責(zé)人批準方可成為我公司的合格供應(yīng)商。Allmaterialssuppliersmusthavetheindustry'sproductionandoperationofthestatutoryqualifications;theproductshouldcomplywiththestatutoryrequirementsandmeetourproductionrequirements;weneedcarryontheassessmentaboutthevalidityandapplicabilityofthesupplier'sproductionsystemandqualityassurancesystem,toconfirmthesupplierscancontinuouslyandstablyproduceanddelivertheproductswhichmeetourrequirements,Becomeaqualifiedsupplierofourcompanyafterfinallyapprovedbyresponsiblepersonofquality.2.1、供應(yīng)商的初選與變更申請Primaryselectandchangerequestofsupplier物料供應(yīng)商，特別是關(guān)鍵物料的供應(yīng)商，應(yīng)保持穩(wěn)定，不經(jīng)常變動。如確實有必要新增供應(yīng)商，應(yīng)以該供應(yīng)商的生產(chǎn)能力、產(chǎn)品質(zhì)量及企業(yè)信譽等情況為選擇依據(jù)，由采購部填寫《供應(yīng)商變更控制表》變更申請部分內(nèi)容，申請中需注明涉及的物料、產(chǎn)品及使用車間，詳述變更理由，并按以下要求索取加蓋供應(yīng)商公章的資料，交品管部審核（如公司名稱不變，生產(chǎn)地址改變同該變更流程）：Materialsuppliers,especiallysuppliersofkeymaterials,shouldremainstable,donotchangefrequently.Ifabsolutelynecessarytoaddnewsupplier,selectionshouldbebasedontheproductioncapacity,productqualityandcompanyreputation,theapplypartofthechangein"SupplierChangeControlForm"shouldbefilledoutbyPurchasingDepartment,theapplicationmustbemarkedrelatedmaterials,productsandtheuseoftheworkshop,detailingthereasonsforchange,accordingtothefollowingforobtainingsupplier’sinformationwiththeofficialsealstamped,deliverthemtoQADept.toaudit(Ifcompanydoesn’tchange,buttheaddresschange,thisalsoshouldbefollowthischangeflow):對于合成車間用物料的生產(chǎn)商，應(yīng)取得《企業(yè)法人營業(yè)執(zhí)照》、《全國工業(yè)產(chǎn)品生產(chǎn)許可證》；如果所提供的物料是實施生產(chǎn)許可證管理的危險化學(xué)品，還應(yīng)取得《安全生產(chǎn)許可證》；如果所提供物料是實施生產(chǎn)許可證管理的藥品或食品，還應(yīng)取得《藥品生產(chǎn)許可證》或《食品衛(wèi)生許可證》；易制毒化學(xué)品的生產(chǎn)商需提供《易制毒化學(xué)品生產(chǎn)備案證明》；劇毒品要求生產(chǎn)商或經(jīng)銷商提供《道路危險貨物運輸許可證》。"同時要求生產(chǎn)商填寫“供應(yīng)商審計問卷（合成車間用物料版）”。Forthemanufacturerofmaterialswhichareusedinsynthesisworkshop,shouldobtains"businesslicense","NationalIndustrialProductsProductionPermit";iftheprovidedmaterialishazardouschemicalswhichisImplementedwiththeproductionlicensemanagement.shouldbeobtain??"safeproductionlicense";ifthematerialprovidedisdrugorfoodwhichiswhichisImplementedwiththeproductionlicensemanagement,alsoshouldbeobtain"drugproductionlicense"or"foodhygienepermit";manufacturersofprecursorchemicalsmustprovide"easyprecursorchemicalsthatproducetherecord";manufacturersordealersofvirulentrequire"Roadtransportofdangerousgoodslicenses”.Alsorequiremanufacturerstofilloutthe"supplierauditquestionnaire(usesyntheticmaterialsworkshopversion)".對于直接接觸藥品的包裝材料供應(yīng)商，應(yīng)取得《企業(yè)法人營業(yè)執(zhí)照》、《藥品包裝用材料和容器注冊證》、質(zhì)量標準等資質(zhì)證明材料，并要求供應(yīng)商填寫“供應(yīng)商審計問卷（包材供應(yīng)商版本）”。Forsupplierwhosepackagingmaterialdirectlycontactwithdrug,shouldobtain“thebusinesslicenseofenterpriselegalperson","drugpackagingmaterialsandcontainersregistrationcard",evidenceofqualitystandardsandotherqualifications,andrequiresupplierstofilloutthe"supplierauditquestionnaire(packagingmaterialssupplierversion)".對于印刷包裝材料供應(yīng)商，視情況提供以下資料：特種行業(yè)許可證；條形碼承印企業(yè)資格認可證；印刷業(yè)經(jīng)營許可證；包裝裝潢印刷品印制許可證；印刷商標單位證書等。Forprintingandpackagingmaterialsuppliers,asthecasemayprovidethefollowinginformation:specialtradelicense;barcodeprintingbusinessaccreditationcertificate;printingbusinesslicense;printedpackagingmaterialslicense;trademarkprintingunitcertificate.如果該物料是從經(jīng)銷商處采購，則應(yīng)取得經(jīng)銷商的《企業(yè)法人營業(yè)執(zhí)照》（正副本）、《危險化學(xué)品經(jīng)營許可證》（對于危險化學(xué)品）、《藥品經(jīng)營許可證》（正副本）、《藥品經(jīng)營質(zhì)量管理規(guī)范認證證書》（GSP）、易制毒化學(xué)品經(jīng)營備案證明（對于易制毒化學(xué)品）和所經(jīng)銷產(chǎn)品生產(chǎn)廠家的上述資料。同時要求經(jīng)銷商填寫“供應(yīng)商審計問卷（經(jīng)銷商版本）”Ifthematerialispurchasedfromthedistributor,thedistributorshouldget"thebusinesslicenseofenterpriselegalperson"(originalandcopies),"hazardouschemicalsbusinesslicense"(forhazardouschemicals),"DrugSupplyCertificate"(originalandcopies),"DrugGMPCertification"(GSP),theprecursorchemicalsmanagementrecordcertificate(forprecursorchemicals)andtheaboveinformationoffactorywhoseproductisdistributed.Alsorequiredealerstofilloutthe"supplierauditquestionnaire(dealerversion)".2.2、供應(yīng)商變更的評估Changeofassessmentofsuppliers2.2.1、采購部將收集到的證照、問卷等材料，交品管部由供應(yīng)商管理員進行審核。PurchasingDepartmentcollectthecertificates,questionnairesandothermaterials,shouldbedelivertotheQADept.checkedbythesupplieradministrator2.2.2、供應(yīng)商管理員確認該公司材料齊全，資質(zhì)符合要求后，給該《供應(yīng)商變更控制表》編號（編號原則為：年份（四位）+流水號（三位），例如：2013年第8個《供應(yīng)商變更控制表》的編號即為2013008），同時確定需要參與變更評估的部門。（其中僅新增經(jīng)銷商，該經(jīng)銷商供應(yīng)的物料為我公司原有合格供應(yīng)商生產(chǎn)的物料時，不需要其它部門進行評估，直接由質(zhì)量負責(zé)人批準）。參與會簽的部門在接到品管部供應(yīng)商管理員的評估通知后，應(yīng)在3個工作日內(nèi)綜合考慮到物料及產(chǎn)品的特性、供應(yīng)商的情況及法規(guī)的要求等內(nèi)容完成評估，給出需要采取的措施，并簽字（蓋章）后交品管部供應(yīng)商管理員，包括而不局限于以下內(nèi)容：Thesupplieradministratorconfirmedthatthecompany'smaterialsarecompletelyandmeetthequalificationrequirements,giveanumbertothis"supplierchangecontrolform"(numberingprinciplesare:year(four)+serialnumber(three),forexample:the8th"supplierchangecontrolform"in2013,sothenumberis2013008),anddeterminethedepartmentwhowillparticipateintheassessmentofchanging.（ifonlyaddeddealers;distributorssupplythematerialsformycompany'soriginalproductionofqualifiedsuppliersofmaterials,itdoesn’tneedotherdepartmentstoassess,butdirectlyapprovalbythequalityresponsibility）.ThedeptwhoparticipateinassessafterreceivingthenoticeofQADept.shouldbefinishassessmentwithin3workingdays,includingtakingintoaccountthecharacteristicsofmaterialsandproducts,supplierconditionsandregulatoryrequirements,etc.,givenmeasurestobetaken,anddelivertosupplierofQADept.aftersignature(seal),includingbutnotlimitedtothefollowing:由技術(shù)部確定是否需要向藥監(jiān)部門報補充申請，如果需要則對照質(zhì)量標準確定是否有SOP規(guī)定以外需要進行的驗證工作項目；TheTechnicalCentertodetermineiftoaddapplicationstothepharmaceuticalsector,ifrequired,accordingtorelativequalitystandardstodeterminewhetherthereneedsvalidationprojectswhichoutsidetheprovisionsofSOP由國際注冊部確定是否需要申報原輔料供應(yīng)商的清單及變更；InternationalRegistrationsDept.shoulddeterminewhethertodeclarethelistandchangeoftherawmaterialssuppliers;由生產(chǎn)車間確定是否需要進行試生產(chǎn)以及試生產(chǎn)規(guī)模，確認試生產(chǎn)所需物料的規(guī)格及用量，如需備案，樣品數(shù)量應(yīng)足夠我公司進行全項檢驗以及3批試生產(chǎn)；如是包裝材料的變更涉及多個產(chǎn)品，需根據(jù)藥品特性等情況初選需進行對比考核的產(chǎn)品名稱。Theworkshoptodetermineifneedtotrialproductionandpilotproductionscale,confirmthespecificationsandconsumptionoftrailproduction,fortherecord,thenumberofsamplesshouldbesufficientforalltestitemsofourcompanyandthreebatchesoftrialproduction;ifthechangesofpackagingmaterialswillinfluenceseveralproduct,mustbeAccordingtothecharacteristicsofprimarydrugtoselecttheproductionnamewhichwillbecomparativeassessment.由生產(chǎn)部對生產(chǎn)車間的評估意見進行確認，并提出補充建議。Theproductiondepartment'sassessmentoftheworkshoptoconfirmandmakeadditionalrecommendations.由品管部（現(xiàn)場QA）綜合技術(shù)和生產(chǎn)部門意見確定穩(wěn)定性考核方案；對審計問卷內(nèi)容進行評估。BytheQADept.(on-siteQA)integratedtechnologyandproductiondepartmentstodeterminethestabilityoftheassessmentprogram;theauditquestionnaireforevaluation.供應(yīng)商管理員在收到反饋信息后集中交給變更管理員，作為變更控制表的附件。Supplierfeedbackreceivedaftertheadministratortochangetheadministratorcentralized,aschangecontroltableaccessories.2.2.3、品管部變更管理員根據(jù)各部門的評估意見制定變更實施方案，品管部經(jīng)理確認。QADept.tochangetheadministrator'sassessmentofthevariousdepartmentstodevelopchangeimplementation,QADept.managertoconfirm.2.2.4、質(zhì)量負責(zé)人根據(jù)各部門評估內(nèi)容，同意或否決變更申請，若同意還應(yīng)批準變更實施方案。如申請獲得批準，由品管部供應(yīng)商管理員以工作聯(lián)系單的方式通知相關(guān)部門，開展下一步工作。Qualityassessmentofthevariousdepartmentsresponsibleforthecontentofpeopleagreeorrejectthechangerequest,ifagreedtochangetheimplementationplanshouldbeapproved.IfapprovedbytheMinistryofsupplierqualitymanagertoworkasinglecontacttonotifytherelevantdepartmentstocarryoutthenextstep.2.3、變更的實施Implementationofchange2.3.1、品管部供應(yīng)商管理員聯(lián)系生產(chǎn)部根據(jù)變更實施方案向采購部發(fā)物料采購計劃，采購部需及時進行采購，且物料必須是對方公司上市銷售的正常產(chǎn)品。QualityDivisionadministratorsupplierimplementationplantochangetheproductiondepartmenttosupplyunderthePurchasingDepartmentprocurementplan,theMinistryoftheneedfortimelysupplyprocurement,andothercompanymaterialsmustbeproperlymarketedproducts.2.3.2、樣品進廠后應(yīng)寄存在與物料儲存條件相適應(yīng)的倉庫中，相應(yīng)的檢驗報告采購部需轉(zhuǎn)交品管部供應(yīng)商管理員，由供應(yīng)商管理員以書面形式通知倉庫保管員請檢。如需備案，采購部還需要向供應(yīng)商管理員提供發(fā)票、長期供貨協(xié)議復(fù)印件?；炇覒?yīng)確保在15個工作日內(nèi)完成樣品檢驗，并向品管部提供報告復(fù)印件作為《供應(yīng)商變更控制表》附件。SampleintotheplantshouldbeinstorageintheLogisticsDeptandmaterialstorageconditionscompatible，PurchasingDepartmentsettheappropriateinspectionreportforwardedtothesupplieradministratoroftheQADept.，thesupplieradministratornotifythestorekeeperinwritingtorequesttocheck.Fortherecord,PurchasingDepartmentalsoneedtoprovideaninvoicetothesupplieradministrator,acopyofthelong-termsupplyagreement.QCDept.shouldensurethatwithin15workingdaystocompletethesampletest,QADept.toprovidecopiesofthereportasa"supplierchangecontrolform"attachment.2.3.3、確認樣品符合驗收標準后，如需要試生產(chǎn)，供應(yīng)管理員應(yīng)通知生產(chǎn)部，由生產(chǎn)部協(xié)調(diào)安排，確保車間能在30個工作日內(nèi)完成。試生產(chǎn)結(jié)束，產(chǎn)品送檢合格且根據(jù)實施方案放入考核箱后生產(chǎn)車間需及時通知生產(chǎn)部，生產(chǎn)部確認后將結(jié)果反饋給品管部供應(yīng)商管理員。整個試生產(chǎn)過程，各車間現(xiàn)場QA應(yīng)全程監(jiān)控。Confirmthesamplesmeettheacceptancestandards,suchastheneedtopre-production,Provideradministratorshallnotifytheproductiondepartment,productiondepartmentcoordinationarrangementstoensurethattheworkshopcanbecompletedwithin30workingdaysTheendoftrialproduction,productinspectionandqualifiedintotheassessmentboxundertheimplementationoftheprogramaftertheworkshopneedtonotifytheproductiondepartment,productiondepartmentwillverifytheresultsbacktothesupplierofQADept.administrator.Theentirepre-productionprocess,theworkshopsiteQAshouldbefullcontrol.2.3.4、化驗室應(yīng)在收到產(chǎn)品應(yīng)在15日內(nèi)完成檢驗。如需要備案，化驗室主任需嚴格按照《已上市化學(xué)藥品變更研究的技術(shù)指導(dǎo)原則（一）》的要求組織進行穩(wěn)定性考核、研究驗證等工作。研究驗證工作包括但不局限于以下內(nèi)容：QCDept.varietiesshouldcompletetheinspectionwithin15days.Suchastheneedfortherecord,QCDept.directortobeinstrictaccordancewith"listedchemicalchangesofthetechnicalguidelines(a)"assessmentofthestabilityrequirementsoftheorganization,researchverificationwork.Validationstudies,includingbutnotlimitedtothefollowing:（1）新舊產(chǎn)地原料藥質(zhì)量對比研究Theoriginofoldandnewcomparativestudyofqualitybulkdrugs（2）新舊原料藥產(chǎn)地生產(chǎn)的API的穩(wěn)定性對比研究TheoriginoftheproductionofoldandnewAPIcomparativestudyofstabilityofagents（3）變更后的API的有關(guān)物質(zhì)、含量等的方法學(xué)適用性驗證工作afterthechangeoftheAPI,contentandotherverificationoftheapplicabilityofthemethodology（4）變更后的3批檢驗報告afterthechangeofthethreebatchesoftestreport（5）變更后3批API3個月的穩(wěn)定性資料changesafterthethreebatchesofAPIstabilitydataforthreemonths品管部驗證管理員需要確認是否有相應(yīng)的“微生物驗證資料”。如果沒有需及時通知化驗室完成該項工作。同時督促化驗室在三個月加速考核結(jié)束30日內(nèi)完成所有數(shù)據(jù)及研究驗證資料的整理。AdministratorsneedtoverifytheQADept.toconfirmwhetherthereisacorresponding"micro-authenticationdata."IfyoudonotneedtonotifyQCDept.tocompletethework.AtthesametimeurgeQCDept.inthethreemonthstoacceleratetheendof30daystocompleteallassessmentdataandresearchtovalidatedatacollation.2.3.5、如需要備案，供應(yīng)商管理員在確認相關(guān)部門的工作均已完成后通知技術(shù)部報補充申請。其中資質(zhì)證明材料、質(zhì)量標準部分由品管部供應(yīng)商管理員匯總并交至技術(shù)部；其它需要的資料由相關(guān)部門負責(zé)提供。技術(shù)部在收到資料后需盡快整理審核資料進行補充申請的申報，受理后需盡快協(xié)調(diào)樣品送檢的相關(guān)工作，包括對照品的采購。Ifrequiredfortherecord,supplieradministratorinidentifyingtherelevantdepartmentshasbeenreportedafternotificationtotheTechnicalCentertoaddapplications.Onequalificationevidence,qualitystandardsinpartbytheMinistryofsupplierqualityandpaytotheadministratorSummaryTechnicalCenter;otherinformationrequiredbytherelevantdepartmentstoprovide.TechnologyDept.receivedtheinformationrequiredtocollateinformationassoonaspossibletosupplementtheapplicationtodeclare,assoonaspossibleafteracceptingtheneedtocoordinatethesubmissionoftherelevantworksamples,includingthesubstanceoftheprocurement.2.3.6、對于公司生產(chǎn)并在國外注冊的原料藥，其所需關(guān)鍵物料的供應(yīng)商變更，品管部應(yīng)與國際注冊部溝通，確定申報該變更所需工作材料與具體程序。Forthecompanyandbulkdrugsregisteredabroad,theyneedtochangethekeysuppliersofmaterials,QADept.shouldberegisteredwiththeMinistryofInternationalcommunication,reportthechangetodetermineworkrequiredmaterialsandspecificprocedures.2.3.7、品管部供應(yīng)商管理員需結(jié)合物料特性、考核結(jié)果等信息判斷現(xiàn)場質(zhì)量審計的方案，同時與關(guān)鍵物料的供應(yīng)商簽訂質(zhì)量協(xié)議，在協(xié)議中應(yīng)當(dāng)明確雙方所承擔(dān)的責(zé)任。Ministryofsupplierqualityrequiresacombinationofmaterialpropertiesadministrator,examinationresultsandotherinformationtodetermineon-sitequalityauditprogram,andwiththesigningofkeymaterialssupplierqualityagreement,theagreementshouldbeclearlytheresponsibilityofbothsides.2.4、供應(yīng)商的批準theapprovalofsupplier所有供應(yīng)商均須由質(zhì)量負責(zé)人批準。對于我公司的新產(chǎn)品，其物料供應(yīng)商由品管部根據(jù)藥品申報資料、工藝驗證以及藥監(jiān)部門的批準件等材料確定，無需填寫供應(yīng)商變更控制表。在采購部補充必要的資料后，即可報請質(zhì)量負責(zé)人批準，列入合格供應(yīng)商清單。AllsuppliersmustbeapprovedbytheresponsiblepersonResponsiblepersonofquality.Formycompany'snewproduct,materialsuppliersbytheQADept.reportingdataaccordingtopharmaceutical,processvalidationandDrugAdministrationapprovaldocumentsandothermaterialstodeterminewithoutcompletesupplierchangecontrolform.InthePurchasingDepartmenttoaddthenecessaryinformation,youcanreporttothepersoninchargeofqualityapproval,includedinthelistofqualifiedsuppliers.2.5、供應(yīng)商變更的確認及追蹤supplierconfirmationandtrackingchanges品管部應(yīng)對變更實施情況給予關(guān)注。如變更涉及新的生產(chǎn)廠家，品管部(相關(guān)車間QA)對相應(yīng)物料的首次使用情況進行追蹤，并將物料及對應(yīng)的成品信息進行記錄；還應(yīng)當(dāng)對變更實施后最初至少三個批次的藥品質(zhì)量進行評估；如進行同步考核的變更，還應(yīng)當(dāng)對該批次藥品進行穩(wěn)定性考察結(jié)果的追蹤等工作；如僅涉及經(jīng)銷商的變更，可省略本環(huán)節(jié)。QADept.shouldchangetheimplementationoftheattention.Ifchangesinvolvenewmanufacturers,QADept.(relatedplantQA)fortheuseofappropriatematerialsforthefirsttimetrack,andfinishedmaterialsandthecorrespondinginformationrecord;shouldalsobechangedaftertheimplementationofthefirstbatchofatleastthreetoassessthequalityofdrugs;suchasassessmentofsynchronizationchanges,shouldalsoexaminethestabilityofthebatchesofproductsfortrackingtheresultsofthework;suchasonlychangesinvolvethedealercanomitthispart.3、供應(yīng)商的日常管理thedailymanagementofsuppliers3.1、品管部每半年更新一次“合格供應(yīng)商名單”，內(nèi)容至少包括物料名稱、規(guī)格、質(zhì)量標準、生產(chǎn)商名稱和地址、經(jīng)銷商（如有）名稱等，并分發(fā)至質(zhì)量負責(zé)人、品管部、采購部、物流部、化驗室、生產(chǎn)部、財務(wù)部、國際注冊部或技術(shù)部等相關(guān)部門，作為物料購入和驗收的依據(jù)，確保未經(jīng)批準的物料不會進入生產(chǎn)系統(tǒng)。如果有新增或取消的供應(yīng)商，供應(yīng)商管理員也應(yīng)及時書面通知上述部門。QADept.isupdatedeverysixmonthsa"qualifiedsuppliers"listincludeatleastthenameofthematerial,specifications,qualitystandards,themanufacturernameandaddressofthedealer(ifany)name,anddistributedtothequalitymanager,QADept.therelevantdepartmentsofthePurchasingDepartment,TransportationDepartment,theQCDept.,productiondepartment,theMinistryofFinance,internationalRegistrationDivisionortechnologycenter,thepurchaseandacceptanceasamaterialbasistoensurethatunauthorizedmaterialswillnotentertheproductionsystem.Ifneworcanceledprovider,theprovideradministratorshallpromptlynotifytheabovedepartmentinwriting.“合格供應(yīng)商名單”中所列出的物料，均需通過經(jīng)批準的供應(yīng)商購買。如供應(yīng)商材料已過期，以深色陰影標示，再次購入該物料前，采購部應(yīng)先補充證照材料；如供應(yīng)商材料即將于半年內(nèi)過期，以淺色陰影標示，采購部應(yīng)關(guān)注對方證照的有效期，確保外購物料的法規(guī)符合性。Thematerialslistedinthe"listofqualifiedsuppliersarerequiredtopurchasethroughanapprovedsupplier.Suchasthesupplierofmaterialshasexpired,markedindarkshadowsonceagaintopurchasethematerialsbeforethePurchasingDepartmentshouldsupplementthecertificationmaterials;suchasthesupplierofthematerialisabouttoexpirewithinsixmonths,markedinlight-coloredshadow,thePurchasingDepartmentshouldbeconcernedaboutthevalidityofeachotherlicensetoensureregulatorycomplianceofpurchasedmaterials.3.2、供應(yīng)商管理員負責(zé)建立和維護供應(yīng)商檔案，檔案內(nèi)容包括供應(yīng)商備案表、資質(zhì)證明文件材料、質(zhì)量協(xié)議、質(zhì)量標準、供應(yīng)商審計問卷、現(xiàn)場質(zhì)量審計報告、定期的再評價報告等?；炇倚鑼悠窓z驗數(shù)據(jù)和報告、供應(yīng)商的檢驗報告、產(chǎn)品穩(wěn)定性考察報告等內(nèi)容進行妥善保管。品管部應(yīng)當(dāng)與關(guān)鍵物料供應(yīng)商簽訂質(zhì)量協(xié)議，在協(xié)議中應(yīng)當(dāng)明確雙方所承擔(dān)的質(zhì)量責(zé)任。SupplierQADept.administratorisresponsibleforestablishingandmaintainingsupplierfiles,thefilecontentsoftherecordsheet,includingsuppliers,materialsqualificationdocuments,qualityagreements,qualitystandards,supplierauditquestionnaire,on-sitequalityauditreports,periodicre-evaluationreportandotherperiodic.QCDept.testingofsamplesrequireddataandreports,inspectionreportssupplier,productstabilitystudyreportsandothercontentforsafekeeping.QADept.shouldbesignedwiththequalityofkeymaterialssupplieragreement;theagreementshouldbeclearlybornebyboththequalityofresponsibility.3.3、采購部應(yīng)盡可能保證同一物料有兩家以上供應(yīng)商，以確保公司的生產(chǎn)需求。在提出變更供應(yīng)商時，采購部應(yīng)充分考慮到變更所需要的時間和新增的風(fēng)險，以避免對生產(chǎn)造成不良影響；其它相關(guān)部門應(yīng)給予充分重視，并積極配合。PurchasingDepartmentshouldensurethatthesamematerialastherearetwoormoresupplierstoensurethecompany'sproductionneeds.Proposedchangesinsuppliers,PurchasingDepartmentshouldfullytakeintoaccountthetimeneededtochangeandnewrisks,inordertoavoidadverseeffectsonproduction;otherrelateddepartmentsshouldgivefullattentionandactivesupport.3.4、供應(yīng)商通過填寫我公司供應(yīng)商審計問卷，向我公司承諾如發(fā)生重大變更將及時通知我公司。Thesuppliercompanysuppliersbycompletingtheauditquestionnaire,thecompanycommittedtomajorchangessuchaswillnotifymycompany.采購部應(yīng)做好與供應(yīng)商的信息溝通工作，確保第一時間了解供應(yīng)商發(fā)生重大變更的信息。重大變更包括：供應(yīng)商名稱、關(guān)鍵人員、生產(chǎn)場所、關(guān)鍵設(shè)備等發(fā)生變化；供應(yīng)商產(chǎn)品的生產(chǎn)工藝、批量發(fā)生重大變化；產(chǎn)品質(zhì)量標準、分析方法發(fā)生變化。如供應(yīng)商資質(zhì)證明材料過期的應(yīng)要求供應(yīng)商及時補充材料，品管部將相關(guān)信息記錄于《供應(yīng)商備案表》中。若發(fā)生生產(chǎn)場所的變更需參照“供應(yīng)商變更流程”執(zhí)行；如發(fā)生關(guān)鍵設(shè)備、產(chǎn)品工藝等重大變更時，品管部供應(yīng)商管理員應(yīng)填寫變更申請，由各相關(guān)部門進行評估，必要時需進行現(xiàn)場質(zhì)量審計，并報請質(zhì)量負責(zé)人批準。PurchasingDepartmentshouldbepreparedtocommunicateinformationwithsuppliers,ensuringthefirsttimeamajorchangeofsupplierinformation.Majorchangesinclude:suppliername,keypersonnel,productionsites,andotherkeyequipmentchanges;supplierproductionprocesses,significantchangesinvolume;productqualitystandards,analyticalmethodschange.Evidencesuchassupplierqualificationexpiredshouldrequiresupplierstoreplenishmaterials,QADept.theinformationrecordedinthe"supplierrecordtable".Ifchangesneedtooccurwithreferencetoproductionsites"supplierchangeprocess"implementation;theeventofkeyequipment,products,processesandothermajorchanges,supplierQADept.administratorshouldcompletethechangerequest,bytherelevantdepartmentstoassess,ifnecessary,beon-sitequalityaudit,andreporttothepersoninchargeofqualityapproval.3.5、物料在進廠檢驗過程中發(fā)現(xiàn)問題化驗室應(yīng)及時記錄，并每個月報告給品管部一次。若在車間使用過程中發(fā)現(xiàn)問題，使用部門應(yīng)遞交偏差報告進入調(diào)查程序，調(diào)查結(jié)果及處理意見應(yīng)及時反饋給供應(yīng)商管理員。ThematerialintheincominginspectionprocessshouldbetimelydetectionofproblemsQCDept.recordsandQADept.toreportonceamonth.Iftheproblemsidentifiedduringtheworkshoptouse,userdepartmentsshouldsubmitdeviationreportsintotheinvestigationprocess,findingsandtreatmentsuggestionsshouldbetimelyfeedbacktothesupplieradministrator.3.6、現(xiàn)場質(zhì)量審計on-sitequalityaudit3.6.1、每年1月，品管部供應(yīng)商管理員結(jié)合供應(yīng)商的審計周期及上一年審計工作等各方面信息，制訂供應(yīng)商年度審計計劃，經(jīng)采購部及品管部經(jīng)理確認后，報請質(zhì)量負責(zé)人批準。供應(yīng)商現(xiàn)場質(zhì)量審計由品管部組織實施。除按計劃執(zhí)行審計以外，當(dāng)出現(xiàn)以下情況時，品管部也應(yīng)盡快安排現(xiàn)場審計：Januaryofeachyear,thePurchasingDepartmentqualitymanagerwiththesupplierandthepreviousyearauditcycleinformationonallaspectsofauditworktodeveloptheannualauditplanproviders,thePurchasingDepartmentandQualityManagerconfirmedandreportedtoResponsiblepersonofqualityapproval.Supplieron-sitequalityauditbytheQADept.organizedandimplemented.Inadditiontoimplementationoftheplanaudits,whenthefollowingconditions,QADept.shouldalsoarrangeforon-siteaudit:（1）產(chǎn)生新的關(guān)鍵物料供應(yīng)商；generateanewkeymaterialsuppliers;（2）進廠物料出現(xiàn)嚴重質(zhì)量問題；intotheplantmaterialhasseriousqualityproblems;（3）供應(yīng)商的生產(chǎn)條件、工藝、質(zhì)量標準和檢驗方法等可能影響質(zhì)量的關(guān)鍵因素發(fā)生重大改變。Thesupplierproductionconditions,technology,qualitystandardsandtestingmethods,thequalityofthekeyfactorsthatmayaffectasignificantchange.3.6.2、每次審計前，由品管部擬定審計方案，組織審計小組。根據(jù)審計小組成員資歷選定審計小組組長。審計小組一般由質(zhì)量和生產(chǎn)部門的人員組成，必要時應(yīng)包括采購和技術(shù)等部門。采購部應(yīng)根據(jù)審計方案與供應(yīng)商協(xié)調(diào)審計日程安排，審計工作實行組長負責(zé)制。Eachaudit,preparedbytheQADept.auditprogram,toorganizetheauditteam.Selectedaccordingtotheauditteammembersqualificationsauditteamleader.Theauditteamconsistsofqualityandproductiondepartmentpersonnel,ifnecessary,includingprocurementandtechnologysector.ThePurchasingDepartmentshouldbearrangedaccordingtotheauditprogramsincoordinationwiththesupplierauditschedule,auditworkoftheteamleaderresponsibilitysystem.3.6.3、現(xiàn)場審計時應(yīng)核實供應(yīng)商資質(zhì)證明文件和檢驗報告的真實性，核實是否具備檢驗條件；應(yīng)對其人員機構(gòu)、廠房設(shè)施和設(shè)備、物料管理、生產(chǎn)工藝流程和生產(chǎn)管理、質(zhì)量控制實驗室的設(shè)備、儀器、文件管理等進行檢查，以全面評估其質(zhì)量保證體系；應(yīng)考慮到物料的特性，結(jié)合我公司實際使用過程中出現(xiàn)的問題，與供應(yīng)商進行有針對性的探討。并起草質(zhì)量協(xié)議Shouldbeverifiedon-siteauditofsupplierqualificationandinspectionreportstoprovetheauthenticityofdocumentstoverifytheavailabilityoftestconditions;respondtoitsstaffagency,plantfacilitiesandequipment,materialsmanagement,productionprocessandproductionmanagement,qualitylaboratoryequipment,apparatus,filemanagement,etc.shouldbeexaminedtofullyassessitsqualityassurancesystem;shouldtakeintoaccountthecharacteristicsofthematerial,combinedwithouractualuseofprocessproblemswithsuppliersfortargetedstudy.Anddraftqualityprotocol3.6.4、現(xiàn)場審計結(jié)束后，審計小組應(yīng)對供應(yīng)商各方面狀況進行分析和匯總，于30個工作日內(nèi)完成審計報告。在審計過程中發(fā)現(xiàn)的問題，品管部和采購部應(yīng)督促對方進行整改并追蹤整改進度，直至對方的整改報告被完全接受。在收到供應(yīng)商整改報告后，應(yīng)對整改措施進行確認放行。并且于下次審計時進行再確認。Afterthesiteaudit,supplierauditteamshouldanalyzethevariousaspectsofthesituationandsummarize,in30workingdaystocompletetheauditreport.Duringtheauditfoundproblems,QADept.andPurchasingDepartmentshouldurgetheothersiderectificationandtrackprogressuntiltheothersideoftherectificationreportisfullyaccepted.AlltheCAPAshavetobeconfirmedwhenreceivingtheformalreport,ifeverythingisok,releasethereport.AndalltheCAPAsshouldbeconfirmedagaininthenextsupplieraudit.3.6.5、拒不接受審計，或經(jīng)審計評估不符合要求的的供應(yīng)商，應(yīng)立即報請質(zhì)量負責(zé)人，質(zhì)量負責(zé)人可取消其合格供應(yīng)商資格。Refusetoaccepttheaudit,orauditedassessmentdoesnotmeettherequirementsofthesupplier,shouldbeimmediatelyreportedtothepersoninchargeofquality,qualitypersoninchargeofqualifiedsuppliersmaycancelitsqualification.3.6.6、審計報告與質(zhì)量協(xié)議各一式兩份，一份交供應(yīng)商，另一份歸入供應(yīng)商檔案，由品管部留存。AuditreportandtheQualityAgreementinduplicate,onetopaysuppliers,andoneclassifiedasvendorfileandretainedbytheQADept.3.6.7、對于需要第三方進行審計的物料，第三方需要具備以下資質(zhì)：熟悉藥品管理相關(guān)法律，法規(guī)和醫(yī)藥行業(yè)標準；具有相關(guān)工作經(jīng)驗。應(yīng)索要審計員的簡歷并由質(zhì)量負責(zé)人審核合格。簽訂審計合同后，方可委托此第三方進行供應(yīng)商審計。審計完成后，需要根據(jù)公司體系，由質(zhì)量負責(zé)人對審計結(jié)果進行效果評估，確認審計內(nèi)容符合公司供應(yīng)商審計要求。審計結(jié)果合格后，方可放行此審計結(jié)果，將相應(yīng)供應(yīng)商列為合格供應(yīng)商。Forthematerialsshouldbeauditedbythethirdpart,thequalificationofthethirdpartshouldincludethefollowingaspects:thethirdpartshouldbefamiliarwiththedrugrelatedregulationsandspecificationsaswellashavingtherelatedworkingexperience.TheCVoftheauditorshouldbeprovidedandcheckedbyqualitydirector.Thethirdpartcanauditthesupplierforusaftersigningagreement.Afteraudit,thequalitydirectorshouldevaluatetheeffectoftheauditconductedbythethirdpart,whethertheauditcanbecompliancewithourrequirement