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1、BasicPrinciplesorrGMP“_GMP奎永忌动ActivePharmaceuticalIngredients原料药Module14Siae7of25ActibePRarIzacexlticalJrgrediezts尾裕加Objectives目的TodiscusstheGMPguidelinesforthemanufactureofActivePharmaceuticalIngredients(APIs)讨论用于指导API生产的GMP指南ToexaminekeyPrablemsexperiencedduringinspectionsofthemanutacturersof.APIs
2、andtoseckPossibleSolutions。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,18.1-18.59Nodule14Sjiae2of25WHO-EDM2ActibePRarIzacelticalJrgrediezts尿裕加AreastobeCovered涉及范围Generalconsiderations总则_Personmel人员。Premises厂房设施多Equipment诛符Sanitation卫生Documentation文件系统Retentionofrecordsandsamples记录和样品的保存Production生
3、产PartThree,18.1-18.59Nodule14Sjiae3o0f25WHO-EDMActibePRarIzacelticalJrgrediezts尿裕加GeneralC0nside【aHonS/总贝Overallcon柱ol余丽控制白ConSistentuniformbatches批致性和均匀性。CompliancewithGMPGMP符合性刁Productior/刀yconltrol友蹄/Generalguidelines总指南Co-operationinproduction协作生产Humanandveterinarypreparations人药和兼范的制怀PartThree,1
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5、接受培训情况PartThree,18.7-18.10。Health健康情况刀DfsEses辫鲁苏歹MHadue14刀0perlttty6汪佩仿厂WHO-EDMActibePRarIzacelticalJrgrediezts尿斜加Premises厂房设施_General总贝刀sUitableconstructiontdenoirorrent洪笛硫芬孜仪婉刀adeqxetelyadapledds希cientsize疗分、恭库技志夥刑关闭刁mix-WPsorcontamination范渡或江标花役刀Iogicnltoorkfiotp合理师工/河痛Specialpurposes特殊要求刁artibio
6、ticsiorionescytostaticsubstmices灰胺、渡羟朱劲肖库吊所刀separatespeciicallydesigedenclosedareas拱亢,挂孝故夙切疲历E妮PartThree,18.11-18.13刀separateairjiandlingsystets指训育公气处琏秀线Nedule14ae6of25WHo-EDMActibePRarzacexlticalJrgrediezts尾斜加Premises厂房设施。Hygiene卫生刀cothestonshing,toilefs孩装、莹河史限泷沥厂、育佳起邦炽h刁eating,Qrinkinesmiolirg忠Par
7、tThree,18.11-18.13Nodule14Sie7of25WHO-EDMActibePRarIzacelticalJrgrediezts尿裕加EquiPntent设备_Design,construction,locationandmaintenance设计、建造、定位和维护刁interidedseclezing,contzminatiog/历盗、莹弯、汤标花役刀nlidatedoperation经恭诅收绘众_Cleaning清活刀sterilisedsedaintained:SOPsyecordsdchecks元将、仙历、维扒:5SOP、功录周复芸PartThree,18.14-18
8、.18Nodule14Sjae8of25WHo-EDh。2ActibePRarIzacelticalJrgrediezts尿裕加EquiPntent设备多Processmonitoringandcontrol工艺监控刀C/f险童石融checked夕乏爹绪鸳蜇Z芥龚刁Records7L/习昔Defectiveequipment不合格设备刁zeobetJnpeliet彤才左残伤宜乡U刀yepaireddoctmerted绍绘扬代吊PartThree,18.14-18.18Nodule14Sie9of25WHO-EDMActibePRarIzacelticalJrgrediezts尿裕加sanita
9、ti0n卫生Writtenprogrammes书面程序刀nlidatedbrpremisesidequiperit/房施胡动施功育狞诅刀gualitystidardbrzoater水历质奈扁惧刀fygieng,eal伟grdclothingprmctices叉央、悦麒周奕裨觊河刀tbgstedisposn1怡仪处形Implementationandtraining实施与培训Practicesnotpermitted:不允许的行为:刀eating,smoking忠汀厂希炎炳刁zzhysienicpractices不叉失行为PartThree,18.19-18.22Nodule14Sjie10of23WHO-EDM
