FDA__21CFR211_GMP法规-20090608[1]

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1、FDA21CFR211GMP法规目录六大体系通用的法规分录B&J..........................................................2质量体系�21CFR211分录E,F,G,I及K�.................................15厂房设施与设备系统�CGMP规定�21CFR211分录C�D�............42生产体系�CGMP21CFR211分录F�................................................50包装和贴签系统�CGMP21CFR211分

2、录G�.....................................55实验室控制系统�CGMP21CFR211分录I和K�.............................63物料系统�CGMP21CFR211分录E和H�.....................................721说明:文件中绿色突出显示的内容是FDA2008年12月8日修订执行的新要求.六大体系通用的法规分录B&JSubpartB--OrganizationandPersonnelB�组织与人员Sec.211.22Responsibilitiesofquali

3、tycontrolunit.211∙22质量控制部门的职责(a)Thereshallbeaqualitycontrolunitthatshallhavetheresponsibilityandauthoritytoapproveorrejectallcomponents,drugproductcontainers,closures,in-processmaterials,packagingmaterial,labeling,anddrugproducts,andtheauthoritytoreviewproductionrecordstoassurethatnoerro

4、rshaveoccurredor,iferrorshaveoccurred,thattheyhavebeenfullyinvestigated.Thequalitycontrolunitshallberesponsibleforapprovingorrejectingdrugproductsmanufactured,processed,packed,orheldundercontractbyanothercompany.质量控制部门的职责包括�批准和拒收所有成份、药品包装容器、密封件、中间体、包装材料、标签及药品�审核批生产�保证不产生差错�或如果发生差错�保证进行充分

5、的调查。本部门负责根据合同�批准或拒收由其它公司生产、加工、包装或贮存的药品。(b)Adequatelaboratoryfacilitiesforthetestingandapproval(orrejection)ofcomponents,drugproductcontainers,closures,packagingmaterials,in-processmaterials,anddrugproductsshallbeavailabletothequalitycontrolunit.质量控制部门应有适当的实验室检验设施用于检验、批准�或拒收�各种成份、药品容器、密封件

6、、包装材料及药品。(c)Thequalitycontrolunitshallhavetheresponsibilityforapprovingorrejectingallproceduresorspecificationsimpactingontheidentity,strength,quality,andpurityofthedrugproduct.本部门负责批准或拒绝影响药品的特性、效价或含量、质量及纯度的所有程序或标准。(d)Theresponsibilitiesandproceduresapplicabletothequalitycontrolunitshall

7、beinwriting;suchwrittenproceduresshallbefollowed.适用于本部门的职责与程序�应成文字材料�并应遵循。Sec.211.25Personnelqualifications211∙25人员资格(a)Eachpersonengagedinthemanufacture,processing,packing,orholdingofadrugproductshallhaveeducation,training,andexperience,oranycombinationthereof,toenableth