GMP供應(yīng)商審計(jì)課件

2023/2/10供應(yīng)商審計(jì)1藥品生產(chǎn)廠對(duì)原料供應(yīng)商的審計(jì)

Pharmaceuticalproductionplantauditstotherawmaterialsuppliers從源頭開(kāi)始，對(duì)產(chǎn)品質(zhì)量的保證Productqualityassurancestartingfromthesource,2023/2/10供應(yīng)商審計(jì)2物料的分類(lèi)Materialclassification物料的分類(lèi)：原料、輔料、包裝材料。

Classification:rawmaterial,excipient,packagingmaterial原料+輔料：起始物料， rawmaterial+excipient:startingmaterial原料： 有活性的物料，API，rawmaterial:API關(guān)鍵物料：對(duì)產(chǎn)品質(zhì)量有關(guān)鍵影響的物料，在原料、輔料、包裝材料中都有關(guān)鍵物料，如何決定是否關(guān)鍵物料，需要我們科學(xué)合理的評(píng)估。Keymaterials:materialshavecriticalimpactonproductquality,keymaterialisintherawmaterials,auxiliarymaterials,packagingmaterials.Howtodecidekeymaterials,weneedascientificandrationalassessment.2023/2/10供應(yīng)商審計(jì)3供應(yīng)商審計(jì)的必要性和重要性

Thenecessityandimportanceofsupplieraudits法律法規(guī)的要求：必要性，Therequirementsfromthelawandregulationsissuedbygovernment中國(guó)GMP的要求：第76條的要求，質(zhì)量管理部門(mén)應(yīng)會(huì)同有關(guān)部門(mén)對(duì)主要物料供應(yīng)商質(zhì)量體系進(jìn)行評(píng)估，

ChineseGMP,ITEM76:QualitydepartmenthastheresponsibilitytoperformtheaudittoassesthequalitysystemofthemainvendorwithrelateddepartmentsWHOGMP第8.8條：質(zhì)量管理負(fù)責(zé)人有義務(wù)協(xié)同其他部門(mén)批準(zhǔn)能提供符合要求的起始原料和包裝材料的供應(yīng)商，WHOGMPitem8.8:Qualitymanagementhavetheresponsibilitywithrelateddepartmentstoapprovethemanufacturers,theyhastheabilitysupplyqualifiedstartingmaterialsandpackagingmaterials,WHOGMP第8.9條：對(duì)供應(yīng)商的評(píng)估特別要重視供應(yīng)商的歷史和所供應(yīng)物料的性質(zhì)，在審計(jì)時(shí)，首先要確定供應(yīng)商符合GMP的能力。WHOGMPitem8.9:Theassesstovendorshouldpayattentiononthehistoryandmaterialcharacteristics,andverifytheabilityofthevendorabouttheyperformtheGMP.2023/2/10供應(yīng)商審計(jì)5供應(yīng)商審計(jì)的必要性和重要性

Thenecessityandimportanceofsupplieraudits藥品內(nèi)在質(zhì)量很大程度上取決于原輔料和包裝材料的質(zhì)量：重要性，Drugqualitydependslargelyonthequalityofrawmaterialsandpackagingmaterials:importance,藥品，制劑產(chǎn)品是由原輔料和包裝材料組成的，Drugs,dosageformdrugproductiscomposedoftheoriginalmaterialsandpackagingmaterials,制劑生產(chǎn)常常只是使用這些原輔料和包裝材料，而不對(duì)它們進(jìn)行提純、精制或預(yù)處理，Dosagedrugproductionareoftenonlyusetheserawmaterialsandpackagingmaterials,andwithoutrefiningorpretreatment所以，很大程度上，制劑的質(zhì)量取決于原輔料和包裝材料的內(nèi)在質(zhì)量，Drugqualitydependslargelyonthequalityofrawmaterialsandpackagingmaterials:importance,近幾年來(lái)，由于對(duì)供應(yīng)商審計(jì)的忽視，已經(jīng)出現(xiàn)了問(wèn)題，甚至藥害事件，張則敬文件夾\PPT培訓(xùn)資料\GMP與藥品生產(chǎn)-藥害事件舉例.ppt

Inrecentyears,duetotheneglectoftheauditofthesupplier,therehavebeenaproblem,oreveninjuryevent2023/2/10供應(yīng)商審計(jì)6供應(yīng)商審計(jì)的職責(zé)

departmentresponsibletothevendoraudit供應(yīng)商審計(jì)與以下部門(mén)密切有關(guān)： thevendorauditisrelatedtofollowingdepartments:生產(chǎn)部門(mén)：是使用物料的部門(mén)，物料質(zhì)量有問(wèn)題，不能生產(chǎn)出優(yōu)質(zhì)的產(chǎn)品，production:isusingmaterial,andwillnotproducequalityproductwithproblemmaterials采購(gòu)部門(mén)：物料進(jìn)廠的第一道把關(guān)，應(yīng)該嚴(yán)格按照質(zhì)量標(biāo)準(zhǔn)進(jìn)行采購(gòu)，purchase:isthefirstdoortocontrol,andshouldpurchasematerialbasedonpre-approvedspecifications,QC部門(mén)：對(duì)進(jìn)廠物料嚴(yán)格把關(guān)的部門(mén)，QC:performstestandcontrol,QA部門(mén)：牽頭對(duì)供應(yīng)商進(jìn)行審計(jì)和作出決定的部門(mén)，當(dāng)然以上部門(mén)都應(yīng)該參與對(duì)供應(yīng)商的審計(jì)，QA:involvesvendorauditandmakesdecision.2023/2/10供應(yīng)商審計(jì)7如何對(duì)供應(yīng)商進(jìn)行審計(jì)

Howtheauditconduct書(shū)面程序必須形成，并得到質(zhì)量部門(mén)領(lǐng)導(dǎo)的批準(zhǔn)，NeedSOP,thathasbeenapprovedbyQA.書(shū)面程序的內(nèi)容： SOPshouldhavefollowingcontents:目的、范圍、責(zé)任者，purpose,scope,responsibilities,物料和受審供應(yīng)商的清單，及其他們的分類(lèi)，materialslist,supplierslist.審計(jì)的頻率、方式和可接受的供應(yīng)商標(biāo)準(zhǔn)，auditfrequency,acceptablespecifications,審計(jì)的內(nèi)容、記錄和評(píng)估報(bào)告，auditcontents,recordsandevaluationreport,供應(yīng)商的批準(zhǔn)和再審計(jì)，vendorapproving,re-audit,合格供應(yīng)商名錄和檔案的管理，等。Approvedvendorlistand,2023/2/10供應(yīng)商審計(jì)9一般供應(yīng)商generalsupplier除了上面所講的供應(yīng)商，其他的就是一般供應(yīng)商，對(duì)他們的審計(jì)可以采用以下方式：Inadditiontotheabovestatedvendor,theotheristhegeneralsupplier,theauditcanbeusedinthefollowingways:定期現(xiàn)場(chǎng)審計(jì)，間隔的時(shí)間可以相對(duì)長(zhǎng)一些，Periodicon-siteaudit,thetimeintervalcanberelativelylonger,定期的書(shū)面審計(jì)，或者問(wèn)卷的形式，請(qǐng)供應(yīng)商及時(shí)填寫(xiě)并反饋，

Regularwrittenaudit,orintheformofthequestionnaire,thesupplierstotimelycompleteandfeedback2023/2/10供應(yīng)商審計(jì)10供應(yīng)商審計(jì)的頻率auditfrequency關(guān)鍵供應(yīng)商：現(xiàn)場(chǎng)審計(jì)，每?jī)赡暌淮危琸eyvendor:insiteaudit,onceeachtwoyears,非關(guān)鍵供應(yīng)商：每?jī)赡暌淮螘?shū)面審計(jì)，配合3-4年現(xiàn)場(chǎng)審計(jì)一次，no-keyvendor:writtenauditonceeachtwoyearsandinsiteaudit,onceeach3-4years,一般供應(yīng)商書(shū)面審計(jì)：每?jī)赡暌淮螘?shū)面審計(jì)，generalvendorwrittenaudit:writtenauditonceeachtwoyears2023/2/10供應(yīng)商審計(jì)11供應(yīng)商審計(jì)的內(nèi)容

auditcontents現(xiàn)場(chǎng)審計(jì)或書(shū)面審計(jì)前，應(yīng)該請(qǐng)供應(yīng)商準(zhǔn)備好的資料：beforeinsiteauditandwrittenaudit,thevendorshouldberequestedtopreparefollowingmaterials:

供應(yīng)商（最好是生產(chǎn)商）的資質(zhì)證明文件，Suppliers(preferablymanufacturers)qualificationdocuments,

所供應(yīng)物料的質(zhì)量標(biāo)準(zhǔn)，Supplythematerialqualitystandards,

組織結(jié)構(gòu)圖，Organizationalchart,

質(zhì)量部門(mén)的書(shū)面職責(zé)，等，Qualitydepartmentinwritingduties.2023/2/10供應(yīng)商審計(jì)13供應(yīng)商審計(jì)的內(nèi)容

auditcontents現(xiàn)場(chǎng)審計(jì)的內(nèi)容：insiteaudit現(xiàn)場(chǎng)檢查：至少包括倉(cāng)庫(kù)、儀器校驗(yàn)和生產(chǎn)現(xiàn)場(chǎng)、化驗(yàn)室，檢查時(shí)，可以按照檢查表列出來(lái)的內(nèi)容進(jìn)行并記錄，記錄應(yīng)該詳盡，Insiteinspection:Atleast,includingwarehouses,instrumentcalibrationandproductionsites,laboratories.Theinspectionshouldbeinaccordancewiththechecklistlistofcontentandrecords,therecordsshouldbedetailed

查閱文件：批記錄、批分析記錄、原輔料分析記錄、計(jì)量器具校驗(yàn)記錄、環(huán)境監(jiān)控記錄、人員培訓(xùn)記錄，人員體檢記錄和相關(guān)的SOP等，查閱的同時(shí)，進(jìn)行詳細(xì)的記錄， Accesstodocuments:batchrecords,analysisrecords,rawmaterialanalysisrecords,measuringinstrumentscalibrationrecords,environmentalmonitoringrecords,personneltrainingrecords,personnelandmedicalrecordsandrelatedSOP,etc.,accessibleatthesametime,detailedrecords,2023/2/10供應(yīng)商審計(jì)14供應(yīng)商審計(jì)的評(píng)估和報(bào)告

Thevendorevaluationandauditreport對(duì)現(xiàn)場(chǎng)審計(jì)的情況進(jìn)行評(píng)估，On-siteaudittoassess評(píng)估的標(biāo)準(zhǔn)：按照SOP中的規(guī)定評(píng)估，Assessmentcriteria:assessment,inaccordancewiththeprovisionsoftheSOP得出結(jié)論,可以采取打分的方法，將得分與標(biāo)準(zhǔn)進(jìn)行比較，得出是否合格的結(jié)論，Conclusion:thescoringmethodcanbetakentocomparescoreswithstandardeligibilityconclusion,撰寫(xiě)報(bào)告，遞交給有關(guān)領(lǐng)導(dǎo)審閱和批準(zhǔn)，Writtenreportthensubmittedtorelevantleadersforreviewandapproval,不管需要供應(yīng)商進(jìn)行整改的，或有其他要求，或沒(méi)有問(wèn)題的，都要向供應(yīng)商發(fā)出書(shū)面的審計(jì)報(bào)告，并要求及時(shí)反饋，可以在收到反饋后再行批準(zhǔn)，Regardlessofthesupplierforrectificationof,orotherrequirements,orthatthereisnoproblem,awrittenauditreportshouldbesenttothesupplier,andtimelyfeedbackisrequired.Andtheapprovalcanbereleasedafterreceivefeedback.2023/2/10供應(yīng)商審計(jì)15合格供應(yīng)商的名錄Approvedvendorlist供應(yīng)商經(jīng)過(guò)批準(zhǔn)，就成為了合格供應(yīng)商，該信息應(yīng)該及時(shí)通知有關(guān)部門(mén)，Thevendorhasbeenapproved,andbecomeanapprovedvendor,theinformationshouldbeinformedtorelateddepartmentsintimelymanner,供應(yīng)商審計(jì)SOP應(yīng)該明確：各責(zé)任部門(mén)應(yīng)該做什么事情，包括合格供應(yīng)商名錄的發(fā)放，SupplierauditSOPshouldbeclear:theresponsibledepartmentsshoulddosomething,includingtheissuanceofthelistofqualifiedsuppliers,合格供應(yīng)商名錄應(yīng)該及時(shí)更新，Listofqualifiedsuppliersshouldbeupdated合格供應(yīng)商名錄應(yīng)該發(fā)到各個(gè)使用的部門(mén)，比如：采購(gòu)部門(mén)、倉(cāng)庫(kù)、取樣人員、化驗(yàn)室人員和生產(chǎn)部門(mén)等，Listofqualifiedsuppliersshouldbesenttothevarioususesectors,suchas:purchasingdepartment,warehouse,samplingpersonnel,laboratorypersonnelandproductiondepartments

2023