歐盟藥品GD及藥品冷鏈技術(shù)

thecompliancegroupStanO’NeillCPAPE2011年會歐盟藥品藥品流通法規(guī)EURegulationsonDrugDistributionsGuidelinesonGoodDistributionPracticeofMedicinalProductsforHumanUse[Article10EUDir92/25/EEC]人用藥品流通質(zhì)量管理指南[歐盟第92/25/EEC號法令第10款]Personnel人員Documentation文件PremisesandEquipment房屋與設(shè)備DeliveriestoCustomers向客戶交付Returns退貨SelfInspections自檢Ensureproductsareauthorised保證產(chǎn)品經(jīng)過批準Storageconditionsareobserved(alltimes)關(guān)注產(chǎn)品儲存條件(任何時候)Preventcontaminationfromotherproducts預(yù)防來自其它產(chǎn)品的污染Ensureadequateturnoverofproducts保證足夠的產(chǎn)品流轉(zhuǎn)量Deliverrightproducts交付產(chǎn)品正確無誤QualitySystemOperatedbyWholesalersshould批發(fā)商的質(zhì)量系統(tǒng)應(yīng)RightAddress發(fā)貨地址正確SatisfactoryPeriod發(fā)貨斯讓用戶滿意Providetracingsystemforfaultyproducts具備追蹤系統(tǒng)，追蹤有問題的產(chǎn)品

EffectiveRecallProcedure有效的召回程序QualitySystemOperatedbyWholesalersshould批發(fā)商的質(zhì)量系統(tǒng)AppointManagementRepresentative-“ResponsiblePerson”-eachdistributioncentre每個分銷中心須指定-“負責人”-即管理代表Appropriatelyqualified適當?shù)馁Y質(zhì)ImplementandmaintainQualitySystem來實施與保持質(zhì)量系統(tǒng)

KeyPersonnel關(guān)鍵人員Appropriateabilityandexperiencetoguaranteeproductsareproperlyhandled有適當?shù)哪芰εc經(jīng)驗來保證產(chǎn)品正確處理Personnel人員Training培訓(xùn)ProvidetrainingforvariousGDPoperations提供不同GDP操作的培訓(xùn)Trainingprogrammes培訓(xùn)計劃Maintaintrainingrecords保存培訓(xùn)記錄Personnel人員Procedures

程序

Writtenproceduresshoulddescribethedifferentoperationswhichmayaffect應(yīng)當有書面規(guī)程來描述不同的操作，它們可能影響：thequalityoftheproducts產(chǎn)品質(zhì)量thedistributionactivity分銷活動

Proceduresfor有以下規(guī)程：-Receiptandcheckingofdeliveries發(fā)送產(chǎn)品的接收/檢查-Storage儲存Cleaningandmaintenanceofpremises

貯存廠房的清潔與維護Documentation文件ProceduresCont’d

程序(續(xù))Recordingofstorageconditions記錄儲存條件Securityonsiteorintransit現(xiàn)場或運送安全Withdrawalfromsaleablestock從銷售倉庫撤回Recordsof -orders記錄

-定單

-returnedproducts-退貨Recallplans召回計劃

Proceduresforvariousoperationsshouldbeapproved,signedanddatedbytheResponsiblePerson

各種規(guī)程均應(yīng)經(jīng)過負責人的批準，簽字與簽發(fā)日期Documentation文件Records

記錄Madewheneachoperationistakingplace每次操作時均應(yīng)記錄

Activitiesandeventsaretraceable活動/事件均可追蹤Readilyavailable方便查閱Retainedfor5yearsatleast 至少保留5年Eachpurchaseandsale 每次采購與銷售有：

Date日期product/quantity產(chǎn)品/數(shù)量nameandaddressofsupplier/consignee發(fā)貨企業(yè)/收貨人的名稱與地址Documentation文件RecordsCont’d

記錄(續(xù))Transactionsbetween以下交易的記錄：

(i)ManufacturersandWholesalers制造企業(yè)與批發(fā)企業(yè)

(ii)BetweenWholesalers批發(fā)企業(yè)之間

ensuretraceabilityoforigin/destinationproductsi.e.Batchnumberstoidentifysuppliersandthosesuppliedwithmedicinalproducts能保證產(chǎn)品起點/終點的追蹤性，如用批號來識別供應(yīng)商及其發(fā)的藥品Documentation文件Suitableandadequatetoensureproperconservation/distribution適用并足以以保證貯存存/分銷正確無無誤Monitoringdevicesshouldbecalibrated監(jiān)控裝置應(yīng)應(yīng)當進行校校準Receiving接收Receivingbaysprotectdeliveries有保護收貨貨的區(qū)域Receivingareaseparatefromstorageareas收貨區(qū)域與與儲存區(qū)域域分開Deliveriesexaminedonreceipt在收貨時檢檢查產(chǎn)品Damage有無損壞correspondstotheorder與定單是否否相符PremisesandEquipment庫房設(shè)施與設(shè)備Storage儲存Medicinalproductsseparatefromothergoods藥品品與與其其它它產(chǎn)產(chǎn)品品分分開開Conditionsspecified-protectfromlight,moisture,below25℃℃規(guī)定定條條件件-避光光,防潮潮,低于于25℃℃Temperaturemonitoringdocumented溫度度監(jiān)監(jiān)測測有有記記錄錄Recordsreviewedregularly定期期審審核核記記錄錄TemperatureMapping.Storageareas/coldrooms溫度度分分布布、、儲儲存存區(qū)區(qū)/冷庫庫PremisesandEquipment庫房房設(shè)設(shè)施施與設(shè)設(shè)備備Ensurealllocationswithinspecifictemperaturerange保證證所所有有區(qū)區(qū)域域都都在在規(guī)規(guī)定定的的溫溫度度范范圍圍內(nèi)內(nèi)>25oC2-8oCPremisesandEquipment庫房房設(shè)設(shè)施施與設(shè)設(shè)備備StorageFacility儲存存設(shè)設(shè)施施Clean清潔潔Freefromlitter,dust,pests無廢廢棄棄物物、、灰灰塵塵、、蟲蟲害害Freefromspillageorbreakage沒有有溢溢出出或或損損壞壞Microcontamination微生生物物污污染染Crosscontamination交叉叉污污染染StockRotation庫存流流轉(zhuǎn)轉(zhuǎn)“FirstinFirstout””Regularchecks“先先進進先先出出””定定期期檢檢查查PremisesandEquipment庫房房設(shè)設(shè)施施與設(shè)設(shè)備備OutofDateorDamagedStock將過期期或或損損壞壞庫庫存存Quarantine隔離離/待檢檢Destroy銷毀毀PremisesandEquipment庫房房設(shè)設(shè)施施與設(shè)設(shè)備備AuthorisedWholesalers批準準的的批批發(fā)發(fā)商商PersonsauthorisedtosupplyMedicinalProducts經(jīng)批批準準可可從從事事藥藥品品流流通通的的人人員員IMBwilllookrandomlyatcustomerlist愛爾爾蘭蘭藥藥品品管管理理局局將將在在客客戶戶清清單單中中隨隨機機抽抽查查SupplyDocument提供供的的文文件件應(yīng)應(yīng)有有：：Date日期期NameandPharmaceuticalForm名稱稱與與藥藥品品劑劑型型Quantitysupplied供應(yīng)應(yīng)數(shù)數(shù)量量DeliveriestoCustomers向客客戶戶發(fā)發(fā)貨貨Supplierandaddressee供應(yīng)應(yīng)商商以以及及地地址址Nameandaddress名稱稱與與地地址址ProductShelfLife產(chǎn)品品有有效效期期Productdispatchedmusthaveaminimumdefinedshelfliferemaining所發(fā)發(fā)送送的的產(chǎn)產(chǎn)品品必必須須具具有有所所規(guī)規(guī)定定最最短短有有效效期期DeliveriestoCustomers向客客戶戶發(fā)發(fā)貨貨Transportation運輸輸Ensurethat保證證：：Identificationisnotlost不丟丟失失標標識識CrossContaminationisavoided避免免交交叉叉污污染染Productsaresecure產(chǎn)品品安安全全Breakage&theftareavoided避免免損損壞壞與與偷偷竊竊Protectedfromunacceptableenvironmentalconditions防止止環(huán)環(huán)境境條條件件不不符符合合要要求求Temperatureiscontrolledduringtransport在運運輸輸中中溫溫度度受受控控DeliveriestoCustomers向客客戶戶發(fā)發(fā)貨貨ColdChain冷鏈鏈Productsrequiringrefrigerationmustbedeliveredin需要冷冷凍產(chǎn)產(chǎn)品必必須在在下列列條件件下發(fā)發(fā)運Refrigeratedtransport冷凍運運輸Insulatedboxes絕熱箱箱Validateworstcasesituationduringtransport驗證在在運輸輸中最最壞情情況狀狀態(tài)Ensureproductdoesnotcomeincontactwithicepacks保證產(chǎn)產(chǎn)品不不接觸觸冰袋袋ResponsiblePerson-ensureadequatedeliveryconditionsmaintained負責人人-保證保保持足足夠的的交付付條件件DeliveriestoCustomers向客戶戶發(fā)貨貨ControlledDrugs受控藥藥物MaintainSecurityChain保持發(fā)發(fā)貨各各環(huán)節(jié)節(jié)的安安全Separatecontroldrugsindeliveriestofacilitatetransfer受控藥藥品要要采用用單獨獨發(fā)送送方式式，方方便移移交Deliverdirecttopharmacistatthehospitalorretailoutlet直接交交到醫(yī)醫(yī)院或或零售售店的的藥劑劑師DeliveriestoCustomers向客戶戶發(fā)貨貨NonDefectiveMedicinalProducts無缺陷陷藥品品SegregationfromSaleableStockuntilchecked與銷售售庫存存相隔隔離，，直到到經(jīng)過過檢查查Productsingoodcondition-originalunwrappedcontainers產(chǎn)品保保持良良好狀狀態(tài)--容器為為原始始包裝裝未經(jīng)經(jīng)開封封Productsstoredunderproperconditions產(chǎn)品在在正確確條件件下儲儲存Remainingshelflifeacceptable仍有可可接受受的有有效期期Returns退貨Productsexaminedandassessedbyauthorised,trainedpersonnel產(chǎn)品由由經(jīng)過過批準準及培培訓(xùn)人人員的的檢測測與評評估Specialstorageconditions-timeelapsedsinceissue特別儲儲存條條件-自從發(fā)發(fā)貨起起的持持續(xù)時時間Maintainrecordsofreturnedgoods保存退退貨記記錄ReturntostockoperatingFIFOSystem退回倉倉庫，，按先先進先先出要要求管管理Returns退貨ProductDisposal產(chǎn)品處處置Returned,RejectedorRecalledProducts退回，，拒絕絕或召召回產(chǎn)產(chǎn)品Decisiondocumented&recordedbyResponsiblePerson決定文文件與與負責責人的的記錄錄Disposalinatimelymanner以及時時的方方式處處置Returns退貨ConductandRecordSelfInspectionstomonitortheimplementationofandcompliancewithGDPGuidelines對執(zhí)行行流通通管理理規(guī)范范情況況進行行自檢檢并做做好記記錄：：SelfInspectionProcedure自檢程程序InspectionReports檢查報報告FollowupActions跟蹤措施InspectionLog檢查日日志SelfInspection自檢QualityManagement質(zhì)量管管理NoQualitySystemavailable沒有質(zhì)質(zhì)量系系統(tǒng)NoSystemforControlofDocumentation-Issue/Retrieval無系統(tǒng)統(tǒng)控制制文件件的發(fā)發(fā)放/與收回回MastercopiesSOPSnotapprovedbyR.Person基準SOP（原版版）沒沒有經(jīng)經(jīng)過負負責人人批準準NoPolicyre.沒有以以下相相關(guān)的的方針針：Minimumacceptableproductdating最短可可接受受產(chǎn)品品有效效期Returnofrefrigeratedproducts冷凍產(chǎn)產(chǎn)品退退貨GDPDeficiencies––General執(zhí)行流流通規(guī)規(guī)范常常中的的見缺缺陷Personnel人員Companytrainingprogrammenotavailable公司沒沒有培培訓(xùn)計計劃NotrainingSOPforGDPoperations沒有培培訓(xùn)流流通管管理規(guī)規(guī)范的的SOPPersonneltrainingnotdocumented人員培培訓(xùn)沒沒有記記錄GDPDeficiencies––General執(zhí)行流流通規(guī)規(guī)范常常中的的見缺缺陷Documentation文件RelevantSOPsnotavailableinareasofoperation在操作作區(qū)域域沒有有相關(guān)關(guān)的SOPSOPsnotavailablefor沒有下下列SOP：Receiptandcheckingofdeliveries對到貨貨的接接收與與檢查查Warehousecleaning/pestcontrol倉庫的的清潔潔/蟲害控控制Temperaturemonitoring溫度監(jiān)監(jiān)測Customercomplaints客戶投投訴GDPDeficiencies––General執(zhí)行流流通規(guī)規(guī)范常常中的的見缺缺陷Customercomplaintsnotclosedoutinatimelymanner沒有及及時處處理（（了結(jié)結(jié)）客客戶的的投訴訴Nocustomercomplaintlogmaintained沒有保保留客客戶投投訴記記錄Service/calibrationreportsnotreviewed沒有審審核校校準/維修報報告Pestcontrolreportsnotreviewed沒有經(jīng)經(jīng)過審審核蟲蟲害控控制報報告Calibrationcerts-acceptableerrorlimitnotspecified校準證證明-沒有具具體規(guī)規(guī)定誤誤差限限度GDPDeficiencies––General執(zhí)行流流通規(guī)規(guī)范常常中的的見缺缺陷PremisesandEquipment庫房與設(shè)備備Unauthorisedproductssupplied發(fā)了未未批準準的產(chǎn)產(chǎn)品Premisesmaintainedinanuntidy/dirtycondition庫房處處于骯骯亂狀狀態(tài)Productsnotstoredonpallets產(chǎn)品沒沒有用用托盤盤儲存存Inadequatesegregationreceiving/picking/dispatchareas接收/檢料/發(fā)放區(qū)區(qū)域沒沒有適適當隔隔離Outofdate/shortdatedstockininventory過期/短有效效期產(chǎn)產(chǎn)品沒沒有庫庫存清清單GDPDeficiencies––General執(zhí)行流流通規(guī)規(guī)范常常中的的見缺缺陷TemperatureMapping溫度分分布Notperformed沒有進進行Productstoredincloseproximitytounitheaters產(chǎn)品近近熱源源儲存存Temperatureprobesnotcalibrated溫度傳傳感器器沒有有經(jīng)過過校準準GDPDeficiencies––General執(zhí)行流流通規(guī)規(guī)范常常中的的見缺缺陷PremisesandEquipmentCont’d庫房與設(shè)備備(續(xù))Temperatureexcursionsincoldroomnotinvestigated冷庫溫度超超出范圍，，沒做調(diào)查查Dataloggersnotcalibratedwithinoperatingrange沒有對數(shù)據(jù)據(jù)自動記錄錄儀在其運運行范圍內(nèi)內(nèi)對校準MDADrugsMDA藥品Inadequatecontrol.Poorsecurity沒有足夠控控制，安全全性不良GDPDeficiencies––General執(zhí)行流通通規(guī)范常常中的見見缺陷Discrepanciesnotadequatelyinvestigated對差異情情況沒有有適當調(diào)調(diào)查Dangerousstoragepractices儲存做法法危險：：RatpoisonstoredoverBabyFoodProducts將毒鼠藥藥儲存在在嬰兒食食品上Organophosphoruscompdsstoredoveropen將有機磷磷化合物物存放在在上面containerspackagingcomponents容器包裝裝成分。。GDPDeficiencies–General執(zhí)行流通通規(guī)范常常中的見見缺陷DeliveriestoCustomers向客戶發(fā)發(fā)貨Coldstorageunitsfordeliveryrefrigeratedproductsnotvalidated發(fā)貨用冷冷藏產(chǎn)品品的冷儲儲存單元元沒有經(jīng)經(jīng)過驗證證Inadequatecontrolre.icepacks沒有足夠夠控制，，如冰袋袋InadequatesecurityofMDAdrugs對于MDA藥品沒有有足夠的的安全性性GDPDeficiencies–General執(zhí)行流通通規(guī)范常常中的見見缺陷Returns退貨NoSOPRe.returnofproducttosaleablestock將退貨產(chǎn)產(chǎn)品到銷銷售倉庫庫無SOPPersonnelnottrainedRe.checkingreturnedgoods沒有對人人員進行行退回貨貨物檢查查的培訓(xùn)訓(xùn)GDPDeficiencies–General執(zhí)行流通通規(guī)范常常中的見見缺陷SelfInspection自檢NoSOPdefiningSelfInspection沒有SOP來規(guī)定自自檢Regularinspectionsnotperformed沒有進行行定期檢檢查Reportsnotissued自檢無報報告Followupactionsnotdocumented跟蹤措施無記記錄Logofinspectionsnotmaintained沒有保存存檢查記記錄GDPDeficiencies–General執(zhí)行流通通規(guī)范常常中的見見缺陷CurrentGDPGuideline現(xiàn)行GDP指南GuidelinesonGDPofMedicinalProductsforHumanUse(94/C63/03)人用藥品品流通管管理規(guī)范范(94/C63/03)http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htmsince1994從1994年開始outdated已過期limitedscope,notdetailed,noclearguidance范圍狹，，不詳細細，缺乏乏明確的的指導(dǎo)性性notreflectingcurrentactivitiesobservedinwholesaledistribution不能反映映現(xiàn)行藥藥品流通通的相關(guān)關(guān)活動Developments––newguidelines制訂-新的指南南ComplexdistributionnetworkswhereallplayersnotwholesaledistributorsasdefinedinDirective2001/83/EC在復(fù)雜的的藥品流流通網(wǎng)絡(luò)絡(luò)中的各各種角色色，并非非都是2001/83/EC號法令中中定義的的批發(fā)商商ThisleadstoinconsistenciesinMSwithrespecttolicensingandcontrolofe.g.virtualwholesalers,outsourcingactivities,brokers,transportation這在藥品品銷售中中，導(dǎo)致致虛擬的的批發(fā)商商、外部部采購活活動、中中間商、、運輸企企業(yè)發(fā)放放許可證證及管理理等方面面的矛盾盾Whyanewguideline?為什么要要一個新新指南?NewlegislativerequirementsarisingfromproposalfromCommission(identificationofGDPrequirementsandobligationsforbrokers,verificationofsuppliers).TheseneedtobeincorporatedintoGDPGuidelines新立法要要求來自自委員會會的提議議(鑒別藥品品流通的的要求以以及中間間商，各各供應(yīng)企企業(yè)的義義務(wù))，這需整整合到GDP指南中Lackofharmonisation––differentprocedures/formatsatCommunitylevelandinternationallevel缺乏協(xié)調(diào)調(diào)–在歐盟層層面與國國際層面面上有不不同的程程序/格式Whyanewguideline?為什么要要一個新新指南?Computerisedsystems計算機化化的系統(tǒng)統(tǒng)Managementofcontractarrangements委托管理理Transparencyinsupplychain供應(yīng)鏈透透明度Transportation運輸Counterfeitcontrols假藥控制制Likelynewcomponents可能的新新的內(nèi)容容Subjectallactorsindistributionchaintoconditionsofwholesaling(exceptpharmacies,retailers)取決于所所有分銷銷鏈的參參與者至至批發(fā)商商條件(除藥房，，零售商商外)Morestringentverificationofsuppliersbywholesalers批發(fā)商對對供貨商商將會有有更嚴格格的檢查查GDPCommunitydatabase(EudraGDP)藥品流通通歐盟數(shù)數(shù)據(jù)庫StrengthenGDPcomplianceinspections:強化藥品品流通的的達標檢檢查:“CompilationofCommunityProceduresforGDP““歐盟將將流通規(guī)規(guī)程進行行匯編””Potentialimpacts潛在影響響GDPDraftingGroupEstablished2008(EMA)歐盟藥品品管理局局流通規(guī)規(guī)范起草草小組于于2008年成立ConceptPaperonrevisionpublished––February2009修訂的概概念文件件已于2009年2月公布DeadlineforComments––May2009征求意見見截止日日期–2009年5月GuidelineonGDP藥品流通通指南welladvanced相當先進進Workinprogress工作進展展harmonisedwithWHOGuideline與WHO指南相協(xié)協(xié)調(diào)/一致draftforpublicconsultationexpectedQ22010預(yù)期在2010年第2季度發(fā)布布草案進進行磋商商someclarificat