GMP规范中英文对照

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1、GMP规范中英文对照Chapter1:GeneralProvisions第一章 总   则Article1:ThisRegulationisenactedinaccordancewiththe"DrugAdministrationLawofThePeople'sRepublicofChina".第一条根据《中华人民共和国药品管理法》规定，制定本规范。 Article2:ThisRegulationispromulgatedasthebasicguidelineformanufacturingandqualitycon

2、trolofpharmaceuticalproducts.ThisRegulationshallbeapplicabletoallthemanufacturingprocessesofdrugpreparationsandtothekeymanufacturingprocessesofrawmaterialswhichmaycausevariationinthequalityoffinishedproducts.第二条本规范是药品生产和质量管理的基本准则。适用于药品制剂生产的全过程、原料药生产中影响成品质量的关键工序

3、。Chapter2:OrganizationandPersonnelArticle3:Apharmaceuticalenterpriseshallestablishproductionandqualitycontroldepartments.Theresponsibilitiesofdepartmentsatalllevelsandpersonnelshallbeclarified,andeachdepartmentshallbestaffedbyanappropriatenumberofmanagementandt

4、echnicalpersonnelwithexpertknowledge,manufacturingexperienceandorganizationability.  第三条药品生产企业应建立生产和质量管理机构。各级机构和人员应职责明确，并配备一定数量的与药品生产相适应的具有专业知识、生产经验及组织能力的管理人员和技术人员。Article4:Theenterprisepersonnelresponsibleforsupervisionofmanufactureandqualitycontrolshall,atami

5、nimum,haveabachelor'sdegreeinmedicine,pharmaceuticals,orrelatedsciences,andhaveappropriateexperienceindrugmanufacturingandqualitycontrol.TheyshallberesponsiblefortheimplementationoftheGMPregulationsandthequalityofproducts.第四条企业主管药品生产管理和质量管理的负责人应具有医药或相关专业大专以上学历，

6、有药品生产和质量管理经验，对本规范的实施和产品质量负责。Article5:Theresponsiblepersonofthemanufactureandqualitycontroldepartmentsshall,ataminimum,haveacollegedegreeofmedicine,pharmaceuticalsorrelatedsciences,haveactualmanagementexperienceinproductionandqualitycontrol,andhavetheabilitytoco

7、rrectlydecideandhandlepracticalproblemsinproductionandqualitycontrol.Themanagersofproductionandqualitycontroldepartmentsshallbeindependentofeachother.第五条药品生产管理部门和质量管理部门的负责人应具有医药或相关专业大专以上学历，有药品生产和质量管理的实践经验，有能力对药品生产和质量管理中的实际问题作出正确的判断和处理。药品生产管理部门和质量管理部门负责人不得互相兼任Ar

8、ticle6:Allpersonnelengagedindrugmanufactureandqualitycontrolshallhavebeenprofessionallyandtechnicallytrainedsoastoacquirethebasictheoryandpracticaltechnicalskills.Personnele