WHO原料药GMP现场检查(中英文)

BasicPrinciplesofGMPGMP根本准那么ActivePharmaceuticalIngredients原料药PartThree,18ActivePharmaceuticalIngredients原料药Objectives目的TodiscusstheGMPguidelinesforthemanufactureofActivePharmaceuticalIngredients(APIs)讨论用于指导API生产的GMP指南ToexaminekeyproblemsexperiencedduringinspectionsofthemanufacturersofAPIsandtoseekpossiblesolutions针对API生产GMP检查过程中所发现关键问题的检查，并寻求可能的解决方案PartThree,18.1–18.59ActivePharmaceuticalIngredients原料药AreastobeCovered涉及范围Generalconsiderations总那么Personnel人员Premises厂房设施Equipment设备Sanitation卫生Documentation文件系统Retentionofrecordsandsamples记录和样品的保存Production生产PartThree,18.1–18.59ActivePharmaceuticalIngredients原料药GeneralConsiderations总那么Overallcontrol全面控制Consistentuniformbatches批一致性和均匀性CompliancewithGMPGMP符合性Production生产qualitycontrol质量控制Generalguidelines总指南Co-operationinproduction协作生产Humanandveterinarypreparations人药和兽药的制备PartThree,18.1–18.6ActivePharmaceuticalIngredients原料药Personnel人员Qualifiedandcompetent资历和资格productionandqualitycontrol生产和质量控制sufficientnumber足够数量education,knowledge,experience学历、知识和经验Organizationalchartwithresponsibilities组织机构图〔包含相关职责〕Writtenjobdescriptionorinstructions书面职位描述或说明Trained接受培训情况Health健康情况Diseases疾病openlesions开放性伤口PartThree,18.7–18.10ActivePharmaceuticalIngredients原料药Premises厂房设施General总那么suitableconstructionandenvironment适宜建筑和环境adequatelyadaptedandsufficientsize充分、适宜和足够的空间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、激素和细胞产品separatespecificallydesignedenclosedareas独立、特别设计的密闭区域separateairhandlingsystems独立的空气处理系统PartThree,18.11–18.13ActivePharmaceuticalIngredients原料药Premises厂房设施Hygiene卫生clothes,washing,toilets着装、清洗和盥洗eating,drinking,smoking吃东西、喝饮料和吸烟PartThree,18.11–18.13ActivePharmaceuticalIngredients原料药Equipment设备Design,construction,locationandmaintenance设计、建造、定位和维护intendeduse,cleaning,contamination用途、清洗、污染控制validatedoperation经验证的操作Cleaning清洗sterilised,used,maintained:SOPs,recordsandchecks灭菌、使用、维护：SOP、记录和复核PartThree,18.14–18.18ActivePharmaceuticalIngredients原料药Equipment设备Processmonitoringandcontrol工艺监控calibrated,checked校验、复核Records记录Defectiveequipment不合格设备removedorlabelled移走或标识repaired,documented维修并记录PartThree,18.14–18.18ActivePharmaceuticalIngredients原料药Sanitation卫生Writtenprogrammes书面程序validatedforpremisesandequipment厂房设施和设备的验证qualitystandardforwater水质质量标准hygiene,healthandclothingpractices卫生、健康和着装标准wastedisposal废物处理Implementationandtraining实施与培训Practicesnotpermitted:不允许的行为：eating,smoking吃东西和吸烟unhygienicpractices不卫生行为PartThree,18.19–18.22ActivePharmaceuticalIngredients原料药Documentation文件系统Masterformulae主要规那么writteninstructions书面指令masterformulacontents主要规那么内容Authorisation授权outdateddocuments过期文件处理Amendments文件修订Batchdocumentation批生产文件batchmanufacturingrecordcontents批生产记录内容contractproduction合同生产datarecording数据记录PartThree,18.23–18.30ActivePharmaceuticalIngredients原料药Recordandreferencesampleretention留样记录和查阅Activitiesaretraceable一切行为可追踪productionandqualitycontrol生产和质量控制Retentionofrecordsandsamples记录和样品的保存retentionperiod保存期PartThree,18.31–18.32ActivePharmaceuticalIngredients原料药Production生产Processingprocedures工艺处理程序masterformula主配方criticalstepsdefinedandvalidated关键步骤确实定和验证Supervision监管Labelling贴标vessels,containers,equipment反响罐、容器、设备dailyactivities–information日常活动信息PartThree,18.33–18.37ActivePharmaceuticalIngredients原料药Production(continued)生产〔接上〕Startingmaterials起始物料receiving,quarantine,sampling接收、待检和取样Testing检测release,reject,storage,labelling放行、拒收、贮存和标识dispensingSOP分发SOPexceptionsforhazardousmaterials危险物品的特别管理Intermediates中间体Testing检测Labelling标贴Storage贮存PartThree,18.38–18.40ActivePharmaceuticalIngredients原料药Production(continued)生产〔接上〕Activepharmaceuticalingredients原料药meetspecifications符合质量标准limitsforresidueandreactants残留和反响物的限量sterileAPIs无菌原料药PartThree,18.41–18.42ActivePharmaceuticalIngredients原料药Production(continued)生产〔接上〕Packaging包装packagingmaterialselection包材选择procedurestopreventerror预防过失的程序labelling,including:标贴，包括：Productname产品名称Quality质量Batchnumber批号Expiryorretestdate有效期或复检期Warnings,ifrequired警示，必要时Storageconditions贮存条件Namesofmanufacturersandsuppliers生产商和供给商名称PartThree,18.43–18.45ActivePharmaceuticalIngredients原料药QualityControl质量控制Independentunit独立单位Duties:Approve,rejectorrelease职责：批准、放行或不放行specificationsandmethods质量标准和检测方法sampling,sanitationandhygiene取样、卫生设施和卫生Reprocessing返工Stability稳定性Complaints投诉Laboratoryaccessandrequirements实验室进入及其要求Contractlaboratories合同实验室PartThree,18.46–18.51ActivePharmaceuticalIngredients原料药StabilityStudies稳定性研究Writtenprogramme书面程序stabilityindicatingmethods稳定性试验〔说明稳定性试验方法〕Samples取样Containers容器storageconditions贮存条件Expiryorretestdate有效期或复检期PartThree,18.46–18.51ActivePharmaceuticalIngredients原料药Self-InspectionandQualityAudits自检和质量审计Regularindependentinspection常规独立审计expertorteamofexperts专家或专家组productionandqualitycontrol生产和质量控制Records记录Storage贮存Suitableconditionsbasedonstabilitystudies基于稳定性研究的适宜条件Distributionrecordsforeachbatch每批分发记录writtenSOP书面SOPfacilitaterecalls推进召回程序PartThree,18.52–18.55ActivePharmaceuticalIngredients原料药ComplaintsandDefects投诉和缺陷Writteninstructions书面指令Promptactionandinvestigation迅速行动和调查recordfacts记录事实Productreviewsystem产品质量回忆系统Rejectmaterials不合格物料Writtenprocedures书面程序startingmaterials,intermediates,packagingmaterials起始物料、中间体、包材Identified识别storagependingfate贮存等待处理PartThree,18.56–18.59ActivePharmaceuticalIngredients原料药GroupSession团体会议IdentifymajordeficienciesexperiencedinGMPinactivepharmaceuticalingredientsmanufacture.识别原料药生产GMP管理中的主要缺陷Arethereanydeficienciesthatshouldpreventmaterialbeingreleased?是否有阻止物料放行的缺陷？Withinwhattimescaleshouldthesedeficienciesbecorrected?该类缺陷的整改期限？Whataretheimplicationsforbulkactivesupplytoyourcountry?大宗原料药供给到你们国家的政策？Ac