【文章內(nèi)容簡介】 60。therepackingoperationswouldbeconductedandconfirmthatthefollowingareinplaceandapproved:::A:供應(yīng)的技術(shù)項(xiàng)目Technicaltermsofsupply.::B:對于第三方，第三方操作現(xiàn)場審計(jì)，技術(shù)/質(zhì)量方協(xié)議和合同F(xiàn)orthirdparties,Siteauditforproposedactivity,technical/qualityagreementsandcontracts.，法規(guī)及批次放行的影響Identifymarketstobesupplied,regulatoryandbatchrelease一級評估包括Level1assessmentinclude：二級評估除了上述內(nèi)容外，還包括：Level2assessmentincludestheseitemsasbelowbesidesthoseinlevel1:，為什么需要重新包裝，出錯的原因在哪里，是否己有針對這一原因的CAPA。Thereasonwhytherepackisrequiredandwhererequiredasaresultofanerror,andconfirmthatthenecessaryCAPAhavebeenaddressed.。2.對法規(guī)和批放行的影響Impactonregulatoryandbatchrelease.3.對產(chǎn)品質(zhì)量的影響，如冷鏈條件包裝完整性的影1.印變化的重新包裝必須在浙江天元生物藥業(yè)有限公司進(jìn)行。Repacklocation.AlltherepackoperationsrelatedwithponentoroverprintingchangingmustbeexecutedinTY,acceptpricelabelsticking.2.如為退貨產(chǎn)品，應(yīng)檢查、檢驗(yàn)和調(diào)查，并有證據(jù)證明退貨產(chǎn)品質(zhì)量未收影響，且經(jīng)質(zhì)量管理部門根據(jù)操作規(guī)程評價后，方可考慮將退貨重新包裝、規(guī)程編號/版本號Number/Version制/修訂部門DepartmentQAVS規(guī)程頁碼PageofPages7/15規(guī)程名稱Title產(chǎn)品重新包裝管理規(guī)程ProductRepackagingManagementforanyproposedrepackingoperation.TheymustthensubmittheformtoQualityforapproval.implications.，如在非冷藏條件下的儲存時間Identifyanyenvironmentalcontrolsrequiredduringrepackingoperations,forexampletimeoutofcoldstore.識別任何與申請的重新包裝相關(guān)的風(fēng)險(xiǎn)及任何的緩解行動Identifyanyrisksassociatedwithproposedrepackingtogetherwithanymitigationplans.確認(rèn)防篡改或防偽標(biāo)志是否會被破壞或者是否需要重新添加Determinewhethertamperevidentoranticounterfeitfeatureswouldneedtobebroken,orarerequired,andwhethertheymustbereappliedoradded.確認(rèn)任何額外的測試或抽樣的要求Identifyanyadditionaltestingandsamplingrequirements.IdentifybatchnumberrequirementsSee.確保任何重新包裝被當(dāng)?shù)氐姆ㄒ?guī)部門批準(zhǔn)（如果需要）。重新包裝的申請人必須在重新包裝申請單中記錄此評估以及重新包裝的理由。必須記錄清晰，詳述重新包裝的流程，包括任何重新包裝操作的控制要求。然后評估報(bào)告須提交給質(zhì)量進(jìn)行批準(zhǔn)EnsurethatanyrepackingisapprovedbylocalRegulatoryAuthoritiesiflocalregulationsrequireit.Therepackagingproposermustdocumentthisassessmentandrationaleforwhytherepackingisjustifiedinarepackingrequestform.Theymustalsodocumentclear,detailedrepackinginstructionsincludingthecontrolsrequired規(guī)程編號/版本號Number/Version制/修訂部門DepartmentQAVS規(guī)程頁碼PageofPages8/15規(guī)程名稱Title產(chǎn)品重新包裝管理規(guī)程ProductRepackagingManagement響、混淆的風(fēng)險(xiǎn)、物料平衡的影響等Impactonproductquality.Suchasimpactoncoldchain,packingintegrity,mixupandreconciliation.4.對追溯性的影響。哪些需要重新包裝，如重新包裝則需要做哪些變動，重新包裝的數(shù)量等Impactontraceability.Whichportionneedtoberecheckedandrepacked,anychangeneedtobedoneifthereisrepacking,andthequantityneedtoberecheckedandrepacked.5.確定防竊起特征是否需要破壞，添加，或重新使用Toconfirmiftemperfeatureneedtobebroken,addedorreused.6.重新包裝的商業(yè)可行性，總費(fèi)用和對供應(yīng)的影響Impactonmercialviability,totalcostandcriticalityofsupply.7.重新包裝仍沿用以前的批號信息Batchnumberwillnotbechangedforrepacking.8.留樣Determineretentionsamples重新發(fā)運(yùn)銷售。評價考慮的因素至少應(yīng)當(dāng)包括藥品的性質(zhì)、所需的貯存條件、藥品的現(xiàn)狀、歷史，以及發(fā)運(yùn)與退貨之間的間隔等因素。不符合貯存和運(yùn)輸要求的退貨應(yīng)當(dāng)在質(zhì)量管理部門的監(jiān)督下予以銷毀。對退貨質(zhì)量有懷疑時，不得重新發(fā)運(yùn)。Ifthereturnedgoodsaregoingtoberepacked,theyshouldbechecked,testedandinvestigatedtoprovethatthequalityisnotimpacted.Itshouldbeassessedbyqualitydepartmentbeforereturngoodsbeingrepackedandshippedout.Theassessmentshouldatleastincludestheproductcharacters,storageconditions,thestatusandhistoryoftheproductsandtimebetweenshipmentandreturn.Goodsthatcannotmeetrequirementshouldbedestroyed.Ifthereisanyhesitateonqualityofreturngoods,theyshouldnotbeshippedout.3.文稿變更Artworkchange4.識別重新包裝可能引起的其他風(fēng)險(xiǎn)及其緩解措施Identifyanyriskassociatedwiththeproposedrecheckingandrepackingtogetherwithanymitigationplans.Note：本SOP范圍之外的情況在實(shí)施之前須得到總部機(jī)構(gòu)的批準(zhǔn)IncasethereisotherrecheckorrepackcaseoutofthescopeofthisSOP.Approvedbyqualitygroupspriortomencingrecheckandrepack圖案文稿及原材料批準(zhǔn)ArtworkandMaterialsApproval如果需要重新創(chuàng)建新的圖案文稿，則所有的與重新包裝組分相關(guān)的打印材料和圖案文稿必須采用圖案文稿控規(guī)程編號/版本號Number/Version制/修訂部門DepartmentQAVS規(guī)程頁碼PageofPages9/15規(guī)程名稱Title產(chǎn)品重新包裝管理規(guī)程ProductRepackagingManagement制程序進(jìn)行批準(zhǔn)（）Ifthereisarequirementtocreatenewartworkthenallprintedmaterialsandartworkrelatingtorepackingponent