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1、文件印制、发放、保管、收回、销毁SOP文件题目SOP-Printing,delivery,filing,recallinganddestructionDocumentTitleofdocuments文件编号文件版本号00(2011)DocumentCodeVersionCode管理类文件种类发放部门ManagementQACategoryofDocumentDepartmentofIssue人员Person姓名/职位签名日期Name/PositionSignatureDate类别Category编写人Compiledby审核人C
2、heckby批准人Approvedby生效日期Validfrom文件分发部门:()Departmentofdocumentdistributed:序号部门名称房间号负责人SerialNo.DepartmentNameRoomNo.Manager12345678910生效日期:版本号:00页码:1/10Validfrom:Versioncode:PageNo.:文件变更历史:Historyofdocumentchanging:版本号变更日期变更内容摘要VersionCodeChangingDateAbstractofChangin
3、gContents建立文件00(2011)2011.05.16Filefoundation生效日期:版本号:00页码:2/10Validfrom:Versioncode:PageNo.:1.SOP的目的Aim建立GMP文件的复制、分发、保管、收回、销毁、撤销程序,使文件保管和使用规范化。ThepurposeofthisSOPistodefineanappropriateprocedurefortheprinting,delivery,keeping,recalling,destructionandrevocationofdocu
4、ments,inordertostandardizekeepingandusingofdocuments.2.范围Scope所有GMP文件的复制、分发、保管、收回、销毁、撤销管理过程。TheSOPmustbeappliedtotheprinting,delivery,keeping,recalling,destructionandrevocationofalltheGMP-relateddocumentsatHuiyu.3.SOP的内容ContentofStandardOperatingProcedure3.1复印/分发/收回P
5、rinting/delivery/recalling公司GMP文件由QA部进行管理,任何部门不得私自复印。若发生以下情况需要使用文件的复印件,须由使用部门填写《文件复印申请表》(见附录1)向QA部提出申请,由QA负责人批准,交付文件管理QA进行复印、分发。GMPdocumentsaremanagedbyQAdepartment,andnoanotherdepartmentshallcopywithoutpermission.Incaseofthefollowingconditiontocopythedocuments,theus
6、edepartmentsapplytoQAdepartmentbyfillingoutthe"ApplicationforDocumentCopy"(seeAnnex1).AfterapprovingbytheheadofQA,theapplicationshouldbedeliveredtodocumentmanageQAfordocumentcopyinganddistribution.3.1.1新编文件复印、分发Copyinganddistributionofnewdocuments新编文件生效后,由文件管理QA根据根据文
7、件首页所示的发放部门确定需复印的份数,并亲自负责复印。复印件应能清晰可辨,复印过程中作废的文件应即时销毁。复印结束后必需在原件及复印文件的每一页上加印“GMP批准文件”。DocumentmanageQAmustdefinehowmanycopieshastobeprintedoffaccordingtothenumberofrelated-departmentsdescribedinthefirstpageofthedocument,andcopythedocumentpersonallyafterthedocumenttake
8、intoforce.Copiesmustbeclearanddistinguishableandtheobsoletepapershouldbedestroyedimmediately.Thecopiesandtheoriginaldocumentmustbes