WHO原料藥GMP現(xiàn)場檢查(中英文)

BasicPrinciplesofGMPGMP根本準(zhǔn)那么ActivePharmaceuticalIngredients原料藥PartThree,18ActivePharmaceuticalIngredients原料藥Objectives目的TodiscusstheGMPguidelinesforthemanufactureofActivePharmaceuticalIngredients(APIs)討論用于指導(dǎo)API生產(chǎn)的GMP指南ToexaminekeyproblemsexperiencedduringinspectionsofthemanufacturersofAPIsandtoseekpossiblesolutions針對(duì)API生產(chǎn)GMP檢查過程中所發(fā)現(xiàn)關(guān)鍵問題的檢查，并尋求可能的解決方案PartThree,18.1–18.59ActivePharmaceuticalIngredients原料藥AreastobeCovered涉及范圍Generalconsiderations總那么Personnel人員Premises廠房設(shè)施Equipment設(shè)備Sanitation衛(wèi)生Documentation文件系統(tǒng)Retentionofrecordsandsamples記錄和樣品的保存Production生產(chǎn)PartThree,18.1–18.59ActivePharmaceuticalIngredients原料藥GeneralConsiderations總那么Overallcontrol全面控制Consistentuniformbatches批一致性和均勻性CompliancewithGMPGMP符合性Production生產(chǎn)qualitycontrol質(zhì)量控制Generalguidelines總指南Co-operationinproduction協(xié)作生產(chǎn)Humanandveterinarypreparations人藥和獸藥的制備PartThree,18.1–18.6ActivePharmaceuticalIngredients原料藥Personnel人員Qualifiedandcompetent資歷和資格productionandqualitycontrol生產(chǎn)和質(zhì)量控制sufficientnumber足夠數(shù)量education,knowledge,experience學(xué)歷、知識(shí)和經(jīng)驗(yàn)Organizationalchartwithresponsibilities組織機(jī)構(gòu)圖〔包含相關(guān)職責(zé)〕Writtenjobdescriptionorinstructions書面職位描述或說明Trained接受培訓(xùn)情況Health健康情況Diseases疾病openlesions開放性傷口PartThree,18.7–18.10ActivePharmaceuticalIngredients原料藥Premises廠房設(shè)施General總那么suitableconstructionandenvironment適宜建筑和環(huán)境adequatelyadaptedandsufficientsize充分、適宜和足夠的空間mix-upsorcontamination混淆或污染控制logicalworkflow合理的工作流程Specialpurposes特殊要求antibiotics,hormones,cytostaticsubstances抗菌、激素和細(xì)胞產(chǎn)品separatespecificallydesignedenclosedareas獨(dú)立、特別設(shè)計(jì)的密閉區(qū)域separateairhandlingsystems獨(dú)立的空氣處理系統(tǒng)PartThree,18.11–18.13ActivePharmaceuticalIngredients原料藥Premises廠房設(shè)施Hygiene衛(wèi)生clothes,washing,toilets著裝、清洗和盥洗eating,drinking,smoking吃東西、喝飲料和吸煙PartThree,18.11–18.13ActivePharmaceuticalIngredients原料藥Equipment設(shè)備Design,construction,locationandmaintenance設(shè)計(jì)、建造、定位和維護(hù)intendeduse,cleaning,contamination用途、清洗、污染控制validatedoperation經(jīng)驗(yàn)證的操作Cleaning清洗sterilised,used,maintained:SOPs,recordsandchecks滅菌、使用、維護(hù)：SOP、記錄和復(fù)核PartThree,18.14–18.18ActivePharmaceuticalIngredients原料藥Equipment設(shè)備Processmonitoringandcontrol工藝監(jiān)控calibrated,checked校驗(yàn)、復(fù)核Records記錄Defectiveequipment不合格設(shè)備removedorlabelled移走或標(biāo)識(shí)repaired,documented維修并記錄PartThree,18.14–18.18ActivePharmaceuticalIngredients原料藥Sanitation衛(wèi)生Writtenprogrammes書面程序validatedforpremisesandequipment廠房設(shè)施和設(shè)備的驗(yàn)證qualitystandardforwater水質(zhì)質(zhì)量標(biāo)準(zhǔn)hygiene,healthandclothingpractices衛(wèi)生、健康和著裝標(biāo)準(zhǔn)wastedisposal廢物處理Implementationandtraining實(shí)施與培訓(xùn)Practicesnotpermitted:不允許的行為：eating,smoking吃東西和吸煙unhygienicpractices不衛(wèi)生行為PartThree,18.19–18.22ActivePharmaceuticalIngredients原料藥Documentation文件系統(tǒng)Masterformulae主要規(guī)那么writteninstructions書面指令masterformulacontents主要規(guī)那么內(nèi)容Authorisation授權(quán)outdateddocuments過期文件處理Amendments文件修訂Batchdocumentation批生產(chǎn)文件batchmanufacturingrecordcontents批生產(chǎn)記錄內(nèi)容contractproduction合同生產(chǎn)datarecording數(shù)據(jù)記錄PartThree,18.23–18.30ActivePharmaceuticalIngredients原料藥Recordandreferencesampleretention留樣記錄和查閱Activitiesaretraceable一切行為可追蹤productionandqualitycontrol生產(chǎn)和質(zhì)量控制Retentionofrecordsandsamples記錄和樣品的保存retentionperiod保存期PartThree,18.31–18.32ActivePharmaceuticalIngredients原料藥Production生產(chǎn)Processingprocedures工藝處理程序masterformula主配方criticalstepsdefinedandvalidated關(guān)鍵步驟確實(shí)定和驗(yàn)證Supervision監(jiān)管Labelling貼標(biāo)vessels,containers,equipment反響罐、容器、設(shè)備dailyactivities–information日?；顒?dòng)信息PartThree,18.33–18.37ActivePharmaceuticalIngredients原料藥Production(continued)生產(chǎn)〔接上〕Startingmaterials起始物料receiving,quarantine,sampling接收、待檢和取樣Testing檢測release,reject,storage,labelling放行、拒收、貯存和標(biāo)識(shí)dispensingSOP分發(fā)SOPexceptionsforhazardousmaterials危險(xiǎn)物品的特別管理Intermediates中間體Testing檢測Labelling標(biāo)貼Storage貯存PartThree,18.38–18.40ActivePharmaceuticalIngredients原料藥Production(continued)生產(chǎn)〔接上〕Activepharmaceuticalingredients原料藥meetspecifications符合質(zhì)量標(biāo)準(zhǔn)limitsforresidueandreactants殘留和反響物的限量sterileAPIs無菌原料藥PartThree,18.41–18.42ActivePharmaceuticalIngredients原料藥Production(continued)生產(chǎn)〔接上〕Packaging包裝packagingmaterialselection包材選擇procedurestopreventerror預(yù)防過失的程序labelling,including:標(biāo)貼，包括：Productname產(chǎn)品名稱Quality質(zhì)量Batchnumber批號(hào)Expiryorretestdate有效期或復(fù)檢期Warnings,ifrequired警示，必要時(shí)Storageconditions貯存條件Namesofmanufacturersandsuppliers生產(chǎn)商和供給商名稱PartThree,18.43–18.45ActivePharmaceuticalIngredients原料藥QualityControl質(zhì)量控制Independentunit獨(dú)立單位Duties:Approve,rejectorrelease職責(zé)：批準(zhǔn)、放行或不放行specificationsandmethods質(zhì)量標(biāo)準(zhǔn)和檢測方法sampling,sanitationandhygiene取樣、衛(wèi)生設(shè)施和衛(wèi)生Reprocessing返工Stability穩(wěn)定性Complaints投訴Laboratoryaccessandrequirements實(shí)驗(yàn)室進(jìn)入及其要求Contractlaboratories合同實(shí)驗(yàn)室PartThree,18.46–18.51ActivePharmaceuticalIngredients原料藥StabilityStudies穩(wěn)定性研究Writtenprogramme書面程序stabilityindicatingmethods穩(wěn)定性試驗(yàn)〔說明穩(wěn)定性試驗(yàn)方法〕Samples取樣Containers容器storageconditions貯存條件Expiryorretestdate有效期或復(fù)檢期PartThree,18.46–18.51ActivePharmaceuticalIngredients原料藥Self-InspectionandQualityAudits自檢和質(zhì)量審計(jì)Regularindependentinspection常規(guī)獨(dú)立審計(jì)expertorteamofexperts專家或?qū)＜医Mproductionandqualitycontrol生產(chǎn)和質(zhì)量控制Records記錄Storage貯存Suitableconditionsbasedonstabilitystudies基于穩(wěn)定性研究的適宜條件Distributionrecordsforeachbatch每批分發(fā)記錄writtenSOP書面SOPfacilitaterecalls推進(jìn)召回程序PartThree,18.52–18.55ActivePharmaceuticalIngredients原料藥ComplaintsandDefects投訴和缺陷Writteninstructions書面指令Promptactionandinvestigation迅速行動(dòng)和調(diào)查recordfacts記錄事實(shí)Productreviewsystem產(chǎn)品質(zhì)量回憶系統(tǒng)Rejectmaterials不合格物料Writtenprocedures書面程序startingmaterials,intermediates,packagingmaterials起始物料、中間體、包材Identified識(shí)別storagependingfate貯存等待處理PartThree,18.56–18.59ActivePharmaceuticalIngredients原料藥GroupSession團(tuán)體會(huì)議IdentifymajordeficienciesexperiencedinGMPinactivepharmaceuticalingredientsmanufacture.識(shí)別原料藥生產(chǎn)GMP管理中的主要缺陷Arethereanydeficienciesthatshouldpreventmaterialbeingreleased?是否有阻止物料放行的缺陷？Withinwhattimescaleshouldthesedeficienciesbecorrected?該類缺陷的整改期限？Whataretheimplicationsforbulkactivesupplytoyourcountry?大宗原料藥供給到你們國家的政策？Ac