【文章內(nèi)容簡(jiǎn)介】 60。therepackingoperationswouldbeconductedandconfirmthatthefollowingareinplaceandapproved:::A:供應(yīng)的技術(shù)項(xiàng)目Technicaltermsofsupply.::B:對(duì)于第三方，第三方操作現(xiàn)場(chǎng)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(jí)評(píng)估包括Level1assessmentinclude：二級(jí)評(píng)估除了上述內(nèi)容外，還包括：Level2assessmentincludestheseitemsasbelowbesidesthoseinlevel1:，為什么需要重新包裝，出錯(cuò)的原因在哪里，是否己有針對(duì)這一原因的CAPA。Thereasonwhytherepackisrequiredandwhererequiredasaresultofanerror,andconfirmthatthenecessaryCAPAhavebeenaddressed.。2.對(duì)法規(guī)和批放行的影響Impactonregulatoryandbatchrelease.3.對(duì)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(mén)根據(jù)操作規(guī)程評(píng)價(jià)后，方可考慮將退貨重新包裝、規(guī)程編號(hào)/版本號(hào)Number/Version制/修訂部門(mén)DepartmentQAVS規(guī)程頁(yè)碼PageofPages7/15規(guī)程名稱(chēng)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(chǔ)存時(shí)間Identifyanyenvironmentalcontrolsrequiredduringrepackingoperations,forexampletimeoutofcoldstore.識(shí)別任何與申請(qǐng)的重新包裝相關(guān)的風(fēng)險(xiǎn)及任何的緩解行動(dòng)Identifyanyrisksassociatedwithproposedrepackingtogetherwithanymitigationplans.確認(rèn)防篡改或防偽標(biāo)志是否會(huì)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(cè)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(mén)批準(zhǔn)（如果需要）。重新包裝的申請(qǐng)人必須在重新包裝申請(qǐng)單中記錄此評(píng)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(píng)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(hào)/版本號(hào)Number/Version制/修訂部門(mén)DepartmentQAVS規(guī)程頁(yè)碼PageofPages8/15規(guī)程名稱(chēng)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(duì)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(dòng)，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(duì)供應(yīng)的影響Impactonmercialviability,totalcostandcriticalityofsupply.7.重新包裝仍沿用以前的批號(hào)信息Batchnumberwillnotbechangedforrepacking.8.留樣Determineretentionsamples重新發(fā)運(yùn)銷(xiāo)售。評(píng)價(jià)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(mén)的監(jiān)督下予以銷(xiāo)毀。對(duì)退貨質(zhì)量有懷疑時(shí)，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(shí)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(hào)/版本號(hào)Number/Version制/修訂部門(mén)DepartmentQAVS規(guī)程頁(yè)碼PageofPages9/15規(guī)程名稱(chēng)Title產(chǎn)品重新包裝管理規(guī)程ProductRepackagingManagement制程序進(jìn)行批準(zhǔn)（）Ifthereisarequirementtocreatenewartworkthenallprintedmaterialsandartworkrelatingtorepackingponent