化妆品GMPC审核报告

1、CAR 1 of 5 Major MinorOrganization:公司名称:Guangzhou Yuerong Cosmetic Co., Ltd.Site(s) audited:审核地址:No.188, Chentai Road, Yongxing Village, Longgui, Taihe Town, Baiyun District, Guangzhou, Guangdong, P.R.ChinaDate(s) of audit(s):审核日期：Auditor(s):审核员:Victor Chen; Henter HuangStandard(s):标准:US-FDA CGMPOrg

2、anization Representative:Mr.Liang Area / Department / Process:生产Document Ref.:参考文件:GZYR02-M04-001-A0Standard Ref.: 标准条款:FDA GMPc 条款 1Issue/Rev. Status:版本状态:A0CAR Close out date:Next VisitDetails of Non-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 FDA CGM

3、P 条款 1 的要求。Premises management is insufficient, e.g. leaving a air-condition hole on floor of semi-finished products storage room , and the air showers entries door control system is out of accurancy . Above against the clause 1 of FDA CGMPrequirement.Organization Representative:公司代表:Mr.LiangAuditor

4、:审核员:Victor Chen; Henter HuangAction taken to eliminate the detected nonconformity: 针对不符合的纠正：Corrective Action taken to prevent recurrence: 避免同样问题再发生的纠正措施：纠正措施：通知设备部人员日内对空调孔洞进行修补，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。Organization Representative:公司代表:Date: 日期:Acceptance of Actio

5、ns / Comments (use additional sheets if necessary): 接纳纠正行动/评论评论 (如有必要时使用附页):Auditor conclusion: NC is 审核员判定：不符合项Maintained 保持Downgraded to : 降级为:-Closed- 关闭Auditor:审核员Date:日期Response required (in months)回复要求 (月数)Major 严重Minor 轻微Corrective Action must be addressed within time frame stated. Verificati

6、on of action will occur at next visit. Additional follow up may be required as indicated. 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Close Out关闭Define确认Close Out关闭1 month1 个月3 months3 个月5 days5 天Next visit下次审核Job / Cert. n:CAN15370 CN12/30930Visit Type:SurveillanceVisit n:2Document:GP6408Issue n

7、:1Page n:0 of 5CAR 2 of Major MinorOrganization:公司名称:Guangzhou Yuerong Cosmetic Co., Ltd.Site(s) audited:审核地址:No.188, Chentai Road, Yongxing Village, Longgui, Taihe Town, Baiyun District, Guangzhou, Guangdong, P.R.ChinaDate(s) of audit(s):审核日期：Auditor(s):审核员:Victor Chen; Henter HuangStandard(s):标准:U

8、S-FDA CGMPOrganization Representative:Mr.Liang Area / Department / Process:生产/ProductionDocument Ref.:参考文件:GZYR02-M04-006-A0Standard Ref.: 标准条款:5.cIssue/Rev. Status:版本状态:A0CAR Close out date:Next VisitDetails of Non-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，

9、没有规定使用的清洗剂及消毒剂品种；以上违反 FDA C GMPc 条款 5.c 的要求。Bulk disinfectant and storged disfectants are not labeled. The usage category of detergent and disinfectant is not specified in EQUIPMENT CLEANING AND DISINFECTANT INSTRUCTION No. GZYR-06-M06-012-A0. Above againstthe clause 5.c of FDA CGMP requirement.Orga

10、nization Representative:公司代表:Mr.LiangAuditor:审核员:Victor Chen; Henter HuangAction taken to eliminate the detected nonconformity: 针对不符合的纠正：Corrective Action taken to prevent recurrence: 避免同样问题再发生的纠正措施：纠正措施：重新修订-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中所使用消毒液的种类及 用法。Organization

11、Representative:公司代表:Date: 日期:Acceptance of Actions / Comments (use additional sheets if necessary): 接纳纠正行动/评论评论 (如有必要时使用附页):Auditor conclusion: NC is 审核员判定：不符合项Maintained 保持Downgraded to : 降级为:-Closed- 关闭Auditor:审核员Date:日期Response required (in months)回复要求 (月数)Major 严重Minor 轻微Corrective Action must b

12、e addressed within time frame stated. Verification of action will occur at next visit. Additional follow up may be required as indicated. 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Close Out关闭Define确认Close Out关闭1 month1 个月3 months3 个月5 days5 天Next visit下次审核Job / Cert. n:CAN15370 CN12/30930Visit

13、Type:SurveillanceVisit n:2Document:GP6408Issue n:1Page n:1 of 5爱 Organization:公司名称:Guangzhou Yuerong Cosmetic Co., Ltd.Site(s) audited:审核地址:No.188, Chentai Road, Yongxing Village, Longgui, Taihe Town, Baiyun District, Guangzhou, Guangdong, P.R.ChinaDate(s) of audit(s):审核日期：Auditor(s):审核员:Victor Chen

14、; Henter HuangStandard(s):标准:US-FDA CGMPOrganization Representative:Mr.Liang Area / Department / Process:生产 /ProductionDocument Ref.:参考文件:GZYR02-M04-017-A0Standard Ref.: 标准条款:5.aIssue/Rev. Status:版本状态:A0CAR Close out date:Next VisitDetails of Non-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

15、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FDA C GMPc条款5.a的要求。When final products lot No.WS170701is filling, the power cut incident happen in audit site. The filling staff pour the residual products of balance bottle into the bulk products bucket, maybe bulk products pollution risk. Above against the cla

16、use 5.a of FDA CGMP requirement.Organization Representative:公司代表:Mr.LiangAuditor:审核员:Victor Chen; Henter HuangAction taken to eliminate the detected nonconformity: 针对不符合的纠正：Corrective Action taken to prevent recurrence: 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，

17、让操作人员清晰地了解并贯彻清场制度。Organization Representative:公司代表:Date: 日期:Acceptance of Actions / Comments (use additional sheets if necessary): 接纳纠正行动/评论评论 (如有必要时使用附页):Auditor conclusion: NC is 审核员判定：不符合项Maintained 保持Downgraded to : 降级为:-Closed- 关闭Auditor:审核员Date:日期Response required (in months)回复要求 (月数)Major 严重M

18、inor 轻微Corrective Action must be addressed within time frame stated. Verification of action will occur at next visit. Additional follow up may be required as indicated. 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Close Out关闭Define确认Close Out关闭1 month 1 个月3 months 3 个月5 days5 天Next visit下次审核Job /

19、Cert. n:CAN15370 CN12/30930Visit Type:2013/7/2223Visit n:2Document:GP6408Issue n:1Page n:0 of 5Organization:公司名称:Guangzhou Yuerong Cosmetic Co., Ltd.Site(s) audited:审核地址:No.188, Chentai Road, Yongxing Village, Longgui, Taihe Town, Baiyun District, Guangzhou, Guangdong, P.R.ChinaDate(s) of audit(s):审

20、核日期：Auditor(s):审核员:Victor Chen; Henter HuangStandard(s):标准:US-FDA CGMPOrganization Representative:Mr.Liang Area / Department / Process:生产/ProductionDocument Ref.:参考文件:GZYR10-M00-001-A0Standard Ref.: 标准条款:5Issue/Rev. Status:版本状态:A0CAR Close out date:Next VisitDetails of Non-Conformity: 不符合的详细描述:生产现场虫

21、害控制管理不足;1)配料间没有打开灭蚊灯 2)成品仓一个门窗无法完全关闭。以上违反 FDA C GMPc 条款 5 的要求。Pest control management is insufficient on production site. Eg.the mosquito killer lamp being not turned onat weighing room, one window door cant be closed hemetically at warehouse. Above against the clause 5 of FDA CGMP requirement.Organ

22、ization Representative:公司代表:Mr.LiangAuditor:审核员:Victor Chen; Henter HuangAction taken to eliminate the detected nonconformity: 针对不符合的纠正：Corrective Action taken to prevent recurrence: 避免同样问题再发生的纠正措施：纠正措施：对怕灭蚊灯重新打开使用，门窗通知设备部在日内进行检修；预防措施：.对现场操作及监督人员进行质量卫生和产品安全方面的培训；.对生产、仓储及相关部门的灭 蚊设施进行一次排查，并纠正已发现的不合格项。

23、Organization Representative:公司代表:Date: 日期:Acceptance of Actions / Comments (use additional sheets if necessary): 接纳纠正行动/评论评论 (如有必要时使用附页):Auditor conclusion: NC is 审核员判定：不符合项Maintained 保持Downgraded to : 降级为:-Closed- 关闭Auditor:审核员Date:日期Response required (in months)回复要求 (月数)Major 严重Minor 轻微Corrective

24、Action must be addressed within time frame stated. Verification of action will occur at next visit. Additional follow up may be required as indicated. 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Close Out关闭Define确认Close Out关闭1 month1 个月3 months3 个月5 days5 天Next visit下次审核Job / Cert. n:CAN15370 CN1

25、2/30930Visit Type:SurveillanceVisit n:2Document:GP6408Issue n:1Page n:1 of 5Organization:公司名称:Guangzhou Yuerong Cosmetic Co., Ltd.Site(s) audited:审核地址:No.188, Chentai Road, Yongxing Village, Longgui, Taihe Town, Baiyun District, Guangzhou, Guangdong, P.R.ChinaDate(s) of audit(s):审核日期：Auditor(s):审核员:

26、Victor Chen; Henter HuangStandard(s):标准:US-FDA CGMPOrganization Representative:Mr.Liang Area / Department / Process:生产/ProductionDocument Ref.:参考文件:GZYR10-M00-001-A0Standard Ref.: 标准条款:1.eIssue/Rev. Status:版本状态:A0CAR Close out date:Next VisitDetails of Non-Conformity: 不符合的详细描述:外包装车间员工没有专用洗手、消毒设施，以上违反FDA C GMPc条款1.e的要求。There is no specified wahing and disinfecting facility for outer packing workers in workshop. Above against the clause 1.e of FDA CGMP requirement.Organization Representative:公司代表:Mr.LiangAuditor:审核员:Victor