21CFR211中英文对照版(SMART)

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1、PART211 211部分-CURRENTGOODMANUFACTURINGPRACTICEFOR—制剂药品的CGMPFINISHEDPHARMACEUTICALSSubpartA--GeneralProvisionsA.总则§211.1-Scope.211∙1范围§211.3-Definitions.211∙3定义SubpartB--OrganizationandPersonnelB．组织与人员§211.22-Responsibilitiesofqualitycontrolunit.211∙22质量控制部门的职责§211.25-Personnelqualifications.2

2、11∙25人员资格§211.28-Personnelresponsibilities.211∙28人员职责§211.34-Consultants.211∙34顾问SubpartC--BuildingsandFacilitiesC．厂房和设施§211.42-Designandconstructionfeatures.211∙42设计与建造特征§211.44-Lighting.211∙44照明§211.46-Ventilation,airfiltration,airheatingand211∙46通风、空气过滤、空气加热与冷却§211.48-Plumbing.211∙48管件§211

3、.50-Sewageandrefuse.211∙50污水和废料§211.52-Washingandtoiletfacilities.211∙52洗涤和盥洗设备§211.56-Sanitation.211∙56卫生§211.58-Maintenance.211∙58保养SubpartD--EquipmentD．设备§211.63-Equipmentdesign,size,andlocation.211∙63设备的设计、尺寸及位置§211.65-Equipmentconstruction.211∙65设备构造§211.67-Equipmentcleaningandmaintenanc

4、e.211∙67设备清洁与保养§211.68-Automatic,mechanical,andelectronic211∙68自动化设备、机械化设备和电子设备equipment.   §211.72-Filters.211∙72过滤器SubpartE--ControlofComponentsandDrugE．成分、药品容器和密封件控制ProductContainersandClosures§211.80-Generalrequirements.211∙80总要求§211.82-Receiptandstorageofuntested211∙82未检验的成份、药品容器和密封件的接收与

5、贮存components,drugproductcontainers,andclosures.§211.84-Testingandapprovalorrejectionof211∙84成份、药品容器和密封件的试验、批准或拒收components,drugproductcontainers,andclosures.§211.86-Useofapprovedcomponents,drugproduct211∙86获准的成份、药品容器和密封件的使用containers,andclosures.§211.87-Retestingofapprovedcomponents,drug211∙8

6、7获准的成份、药品容器和密封件的复检productcontainers,andclosures.§211.89-Rejectedcomponents,drugproduct211∙89拒收的成份、药品容器和密封件containers,andclosures.§211.94-Drugproductcontainersandclosures.211∙94药品密封容器和密封件SubpartF--ProductionandProcessControlsF.生产和加工控制§211.100-Writtenprocedures;deviations.211∙100成文的规程、偏差§211.10

7、1-Charge-inofcomponents.211∙101成分的控制§211.103-Calculationofyield.211∙103产量计算§211.105-Equipmentidentification.211∙105设备鉴别§211.110-Samplingandtestingofin-process211∙110中间体和药品的取样与检验materialsanddrugproducts.§211.111-Timelimitationsonproduction.211