化妆品GMPC审核报告--CAR

CCoorrrreeccttiivveeAAccttiioonnRReeqquueessttCCAARR11ooff55MajorMinorOrganization:公司名称:GuangzhouYuerongCosmeticCo.,Ltd.Site(s)audited:审核地址:No.188,ChentaiRoad,YongxingVillage,Longgui,TaiheTown,BaiyunDistrict,Guangzhou,Guangdong,P.R.ChinaDate(s)ofaudit(s):审核日期：2013/7/22~23Auditor(s):审核员:VictorChen;HenterHuangStandard(s):标准:US-FDACGMPOrganizationRepresentative:Mr.Liang梁波先生Area/Department/Process:生产DocumentRef.:参考文件:GZYR02-M04-001-A0StandardRef.:标准条款:FDAGMPc条款1Issue/Rev.Status:版本状态:A0CARCloseoutdate:NextVisitDetailsofNon-Conformity:不符合的详细描述:基础设施管理维护不足,如：1．洁净车间内半成品存贮间1-2楼板有一个空调孔洞；2．洁净车间风淋室入口感应系统不能准确控制门禁开合;以上违反FDACGMP条款1的要求。Premisesmanagementisinsufficient,e.g.leavingaair-conditionholeonfloorofsemi-finishedproductsstorageroom,andtheairshower’sentriesdoorcontrolsystemisoutofaccurancy.Aboveagainsttheclause1ofFDACGMPrequirement.OrganizationRepresentative:公司代表:Mr.LiangAuditor:审核员:VictorChen;HenterHuangActiontakentoeliminatethedetectednonconformity:针对不符合的纠正：CorrectiveActiontakentopreventrecurrence:避免同样问题再发生的纠正措施：纠正措施：通知设备部人员３日内对空调孔洞进行修补，１５日内完成对风淋间入口感应的调整。预防措施：针对以上硬件不合格项，进行一次硬件全面排查，找出存在隐患的硬件设施并予以纠正。OrganizationRepresentative:公司代表:Date:日期:AcceptanceofActions/Comments(useadditionalsheetsifnecessary):接纳纠正行动/评论评论(如有必要时使用附页):Auditorconclusion:NCisMaintained–Downgradedto:-Closed审核员判定：不符合项保持–降级为:-关闭Auditor:审核员Date:日期Responserequired(inmonths)回复要求(月数)Major严重Minor轻微CorrectiveActionmustbeaddressedwithintimeframestated.Verificationofactionwilloccuratnextvisit.Additionalfollowupmayberequiredasindicated.纠正行动必须于时限完成。将于下次拜访时验证该行动的果效。按显示进行附加跟进。Define确认CloseOut关闭Define确认CloseOut关闭1month1个月3months3个月5days5天Nextvisit下次审核CCoorrrreeccttiivveeAAccttiioonnRReeqquueessttCCAARR22ooff…………MajorMinorOrganization:公司名称:GuangzhouYuerongCosmeticCo.,Ltd.Site(s)audited:审核地址:No.188,ChentaiRoad,YongxingVillage,Longgui,TaiheTown,BaiyunDistrict,Guangzhou,Guangdong,P.R.ChinaDate(s)ofaudit(s):审核日期：2013/7/22~23Auditor(s):审核员:VictorChen;HenterHuangStandard(s):标准:US-FDACGMPOrganizationRepresentative:Mr.Liang梁波先生Area/Department/Process:生产/ProductionDocumentRef.:参考文件:GZYR02-M04-006-A0StandardRef.:标准条款:5.cIssue/Rev.Status:版本状态:A0CARCloseoutdate:NextVisitDetailsofNon-Conformity:不符合的详细描述:生产现场使用的分装消毒液和消毒液存贮桶没有明确标识；生产设备清洁消毒管理制度文件编号GZYR-06-M06-012-A0，没有规定使用的清洗剂及消毒剂品种；以上违反FDACGMPc条款5.c的要求。Bulkdisinfectantandstorgeddisfectantsarenotlabeled.TheusagecategoryofdetergentanddisinfectantisnotspecifiedinEQUIPMENTCLEANINGANDDISINFECTANTINSTRUCTIONNo.GZYR-06-M06-012-A0.Aboveagainsttheclause5.cofFDACGMPrequirement.OrganizationRepresentative:公司代表:Mr.LiangAuditor:审核员:VictorChen;HenterHuangActiontakentoeliminatethedetectednonconformity:针对不符合的纠正：CorrectiveActiontakentopreventrecurrence:避免同样问题再发生的纠正措施：纠正措施：重新修订ＧＺＹＲ-０６-Ｍ０６-１２-Ａ０的管理制度文件，并按要求对现场的消毒液进行分类《品种》进行标识。预防措施：对操作现场的标识重新进行检查，并明确相关的管理制度文件及ＳＯＰ中所使用消毒液的种类及用法。OrganizationRepresentative:公司代表:Date:日期:AcceptanceofActions/Comments(useadditionalsheetsifnecessary):接纳纠正行动/评论评论(如有必要时使用附页):Auditorconclusion:NCisMaintained–Downgradedto:-Closed审核员判定：不符合项保持–降级为:-关闭Auditor:审核员Date:日期Responserequired(inmonths)回复要求(月数)Major严重Minor轻微CorrectiveActionmustbeaddressedwithintimeframestated.Verificationofactionwilloccuratnextvisit.Additionalfollowupmayberequiredasindicated.纠正行动必须于时限完成。将于下次拜访时验证该行动的果效。按显示进行附加跟进。Define确认CloseOut关闭Define确认CloseOut关闭1month1个月3months3个月5days5天Nextvisit下次审核oorrrreeccttiivveeAAccttiioonnRReeqquueessttCCAARR33ooff55Job/Cert.n°:CAN15370CN12/30930VisitType:2013/7/22~23Visitn°:2Document:GP6408Issuen°:1Pagen°:4of6MajorMinor爱Organization:公司名称:GuangzhouYuerongCosmeticCo.,Ltd.Site(s)audited:审核地址:No.188,ChentaiRoad,YongxingVillage,Longgui,TaiheTown,BaiyunDistrict,Guangzhou,Guangdong,P.R.ChinaDate(s)ofaudit(s):审核日期：2013/7/22~23Auditor(s):审核员:VictorChen;HenterHuangStandard(s):标准:US-FDACGMPOrganizationRepresentative:Mr.Liang梁波先生Area/Department/Process:生产/ProductionDocumentRef.:参考文件:GZYR02-M04-017-A0StandardRef.:标准条款:5.aIssue/Rev.Status:版本状态:A0CARCloseoutdate:NextVisitDetailsofNon-Conformity:不符合的详细描述:审核现场罐装产品批WS170701因突发停电，清场时罐装员工将用于平衡小包装量的剩余产品直接倒回成品大周转桶，存在批产品污染风险；以上违反FDACGMPc条款5.a的要求。WhenfinalproductslotNo.WS170701isfilling,thepowercutincidenthappeninauditsite.Thefillingstaffpourtheresidualproductsofbalancebottleintothebulkproductsbucket,maybebulkproductspollutionrisk.Aboveagainsttheclause5.aofFDACGMPrequirement.OrganizationRepresentative:公司代表:Mr.LiangAuditor:审核员:VictorChen;HenterHuangActiontakentoeliminatethedetectednonconformity:针对不符合的纠正：CorrectiveActiontakentopreventrecurrence:避免同样问题再发生的纠正措施：纠正措施：对较受污染的半成品料休进行重新检测，待确定合格后再进行下工序生产；预防措施：由生产部组织相关人员进行清场制度的强化培训，让操作人员清晰地了解并贯彻清场制度。OrganizationRepresentative:公司代表:Date:日期:AcceptanceofActions/Comments(useadditionalsheetsifnecessary):接纳纠正行动/评论评论(如有必要时使用附页):Auditorconclusion:NCisMaintained–Downgradedto:-Closed审核员判定：不符合项保持–降级为:-关闭Auditor:审核员Date:日期Responserequired(inmonths)回复要求(月数)Major严重Minor轻微CorrectiveActionmustbeaddressedwithintimeframestated.Verificationofactionwilloccuratnextvisit.Additionalfollowupmayberequiredasindicated.纠正行动必须于时限完成。将于下次拜访时验证该行动的果效。按显示进行附加跟进。Define确认CloseOut关闭Define确认CloseOut关闭1m