化妝品GMPC審核報(bào)告--CAR

1、Corrective Action RequestCAR 1 of 5匚 Major 匚 MinorOrganization:公司名稱(chēng):Guangzhou Yuerong Cosmetic Co., Ltd.Site(s) audited:審核地址：No.188, Chentai Road, YongxingVillage, Longgui, Taihe Town, Baiyun District,Guangzhou, Guangdong,P.R.ChinaDate(s) of audit(s):審核日期：2I23Auditor(s):審核員:Victor Chen; Henter Huang

2、Standard(s):標(biāo)準(zhǔn)：US-FDA CGMPOrganization Representative:Mr.LiangArea / Department / Process:生產(chǎn)Document Ref.:參考文件：GZYR02-M04-001-A0Standard Ref.:標(biāo)準(zhǔn)條款:FDA GMPc 條款 1Issue/Rev. Status:版本狀態(tài)：A0CAR Close out date:Next VisitDetails of Non-Conformity: 不符合的詳細(xì)描述：基礎(chǔ)設(shè)施管理維護(hù)不足，如：1 .潔凈車(chē)間內(nèi)半成品存貯間 1-2樓板有一個(gè)空調(diào)孔洞；2.潔凈車(chē)間風(fēng)淋室

3、入口感應(yīng)系統(tǒng)不 能準(zhǔn)確控制門(mén)禁開(kāi)合；以上違反FDA CGMP條款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 shower s entries door control system is out of accurancy . Above against the clause 1 of FDA CGMP requirement.Organization Represe

4、ntative: 公司彳表：Mr.LiangAuditor:審核員：Victor Chen; Henter HuangAction taken to eliminate the detected nonconformity: 針對(duì)不符合的糾正：Corrective Action taken to prevent recurrence:避免同樣問(wèn)題再發(fā)生的糾正措施：糾正措施：通知設(shè)備部人員3日內(nèi)對(duì)空調(diào)孔洞進(jìn)行修補(bǔ)，1 5日內(nèi)完成對(duì)風(fēng)淋間入口感應(yīng)的調(diào)整。預(yù)防措施：針對(duì)以上硬件不合格項(xiàng)，進(jìn)行一次硬件全面排查，找出存在隱患的硬件設(shè)施并予以糾正Organization Representative:Da

5、te:日期:公司彳表：Acceptance of Actions / Comments (use additional sheets if nMessa。接納糾正行動(dòng) /評(píng)論評(píng)論(如有必要時(shí)使用附頁(yè)):Auditor conclusion: NC is 匚I Maintained -匚I Downgraded to :- Closed審核員判定：不符合項(xiàng)二I保持-降級(jí)為：-口關(guān)閉Auditor:審核員Date:日期Response required (in months)回復(fù)要求(月數(shù))PMajor嚴(yán)重Minor輕微Corrective Action must be addressed wit

6、hin time frame stated. Verification of actionwill occur at next visit. Additional follow up may be required as indicated.糾正行動(dòng)必須于時(shí)限完成。將于下次拜訪時(shí)驗(yàn)證該行動(dòng)的果效。按顯示進(jìn)行附加跟進(jìn)。Define 確Close Out3Define 確認(rèn)Close Out關(guān)閉1 month1個(gè)月3 months3個(gè)月5 days5天Next visit下次審核Corrective Action RequestCAR 2 of 匚 Major 匚 MinorOrganizatio

7、n:公司名稱(chēng):Guangzhou Yuerong Cosmetic Co., Ltd.Site(s) audited: 審核地址：No.188, Chentai Road, YongxingVillage, Longgui, Taihe Town, Baiyun District,Guangzhou, Guangdong,P.R.ChinaDate(s) of audit(s):審核日期：1Auditor(s):審核員:Victor Chen; Henter HuangStandard(s):標(biāo)準(zhǔn)：US-FDA CGMPOrganization Representative:Mr.LiangA

8、rea / Department / Process:生產(chǎn) /ProductionDocument Ref.: 參考文件:GZYR02-M04-006-A0Standard Ref.:標(biāo)準(zhǔn)條款:5.cIssue/Rev. Status:版本狀態(tài)：A0CAR Close out date:Next VisitDetails of Non-Conformity: 不符合的詳細(xì)描述：生產(chǎn)現(xiàn)場(chǎng)使用的分裝消毒液和消毒液存貯桶沒(méi)有明確標(biāo)識(shí)；生產(chǎn)設(shè)備清潔消毒管理制度文件編號(hào)GZYR-06-M06-012-A0 ,沒(méi)有規(guī)定使用的清洗劑及消毒劑品種；以上違反 FDA C GMPc條款5.c的要求。Bulk di

9、sinfectant 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 against the clause 5.c of FDA CGMP requirement.Organization Representative:公司彳表：Mr.LiangAuditor:審核員：V

10、ictor Chen; HenterHuangAction taken to eliminate the detected nonconformity: 針對(duì)不符合的糾正：Corrective Action taken to prevent recurrence:避免同樣問(wèn)題再發(fā)生的糾正措施：糾正措施：重新修訂GZYR-0 6 -M0 6 - 1 2 - A 0的管理制度文件，并按要求對(duì)現(xiàn)場(chǎng)的消毒液進(jìn)行分類(lèi)品種進(jìn)行標(biāo)識(shí)。預(yù)防措施：對(duì)操作現(xiàn)場(chǎng)的標(biāo)識(shí)重新進(jìn)行檢查，并明確相關(guān)的管理制度文件及SOP中所使用消毒液的種類(lèi)及 用法。Organization Representative:Date:日期:公

11、司彳表：Acceptance of Actions / Comments (use additional sheets if necessary)接納糾正行動(dòng) /評(píng)論評(píng)論(如有必要時(shí)使用附頁(yè)):Auditor conclusion: NC is 匚I Maintained -匚I Downgraded to :- Closed審核員判定：不符合項(xiàng)匚|保持-降級(jí)為：-口關(guān)閉Auditor:審核員Date:日期Response required (in months)回復(fù)要求(月數(shù))Major嚴(yán)重Minor輕微Corrective Action must be addressed within t

12、ime frame stated. Verification of actionwill occur at next visit. Additional follow up may be required as indicated.糾正行動(dòng)必須于時(shí)限完成。將于下次拜訪時(shí)驗(yàn)證該行動(dòng)的果效。按顯示進(jìn)行附加跟進(jìn)。Define 確 以Close Out旬Define 確認(rèn)Close Out關(guān)閉1 mnnth I I mon LI I2 mnnthQ monTTT。今日35 days5天Next visit下次審核orrective Action RequestCAR 3 of 5| | Major m

13、 I Minor爰Organization:公司名稱(chēng)：Guangzhou Yuerong Cosmetic Co., Ltd.Site(s) audited:審核地址：No.188, Chentai Road, YongxingVillage, Longgui, Taihe Town, Baiyun District,Guangzhou, Guangdong,P.R.ChinaDate(s) of audit(s):審核日期：1Auditor(s):審核員:Victor Chen; Henter HuangStandard(s):標(biāo)準(zhǔn)：US-FDA CGMPOrganization Repre

14、sentative:Mr.LiangArea / Department / Process:生產(chǎn) /ProductionDocument Ref.: 參考文件:GZYR02-M04-017-A0Standard Ref.:標(biāo)準(zhǔn)條款:5.aIssue/Rev. Status:版本狀態(tài)：A0CAR Close out date:Next VisitDetails of Non-Conformity: 不符合的詳細(xì)描述：審核現(xiàn)場(chǎng)罐裝產(chǎn)品批 WS170701 大周轉(zhuǎn)桶，存在批產(chǎn)品污染風(fēng)險(xiǎn)；以 When final products lot No.WS1707 pour the residual pro

15、ducts of balanc risk. Above against the clause 5.a of因突發(fā)停電，清場(chǎng)時(shí)罐裝員工將用于平衡小包裝量的剩余產(chǎn)品直接倒回成品 、上違反FDA C GMPc條款5.a的要求。01is filling, the power cut incident happen in audit site. The filling staff ;e bottle into the bulk products bucket, maybe bulk products pollution FDA CGMP requirement.Organization Represen

16、tative: 公司彳表：Mr.LiangAuditor:審核員：Victor Chen;Henter HuangAction taken to eliminate the detected nonconformity:針對(duì)不符合的糾正：Corrective Action taken to prevent recurrence:避免同樣問(wèn)題再發(fā)生的糾正措施：糾正措施：對(duì)較受污染的半成品料休進(jìn)行重新檢測(cè)，待確定合格后再進(jìn)行下工序生產(chǎn)；預(yù)防措施：由生產(chǎn)部組織相關(guān)人員進(jìn)行清場(chǎng)制度的強(qiáng)化培訓(xùn)，讓操作人員清晰地了解并貫徹清場(chǎng)制度。Organization Representative: 公司彳表：Dat

17、e:日期：Acceptance of Actions / Comments （use additional sheets if nessa相接納糾正行動(dòng) /評(píng)論評(píng)論（如有必要時(shí)使用附頁(yè)）：Auditor conclusion: NC is 匚1審核員判定：不符合項(xiàng)Maintained -1 1 Downgraded to :- Closed二1保持-匚1降級(jí)為：-關(guān)閉Auditor:審核員Date:日期Response required (in months)回復(fù)要求(月數(shù))Major嚴(yán)重Minor輕微Corrective Action must be addressed within tim

18、e frame stated. Verification of actionwill occur at next visit. Additional follow up may be required as indicated.糾正行動(dòng)必須于時(shí)限完成。將于下次拜訪時(shí)驗(yàn)證該行動(dòng)的果效。按顯示進(jìn)行附加跟進(jìn)。Define 確以Close Out皿Define確認(rèn)Close Out關(guān)閉1 month3 months-3-45 days5天Next visit下次審核Corrective Action RequestCAR 4 0f 5Job / Cert. n : CAN15370 CN12/3093

19、0Visit Type:2013/7/2223Visit n : 2Document:GP6408Issue n。：1Page n:3 of 6匚 Major 匚 MinorOrganization:公司名稱(chēng):Guangzhou Yuerong Cosmetic Co., Ltd.Site(s) audited: 審核地址：No.188, Chentai Road, YongxingVillage, Longgui, Taihe Town, Baiyun District,Guangzhou, Guangdong,P.R.ChinaDate(s) of audit(s):審核日期：Audito

20、r(s):審核員:Victor Chen; Henter HuangStandard(s):標(biāo)準(zhǔn)：US-FDA CGMPOrganization Representative:Mr.LiangArea / Department / Process:生產(chǎn) /ProductionDocument Ref.: 參考文件:GZYR10-M00-001-A0Standard Ref.:標(biāo)準(zhǔn)條款:5Issue/Rev. Status:版本狀態(tài)：A0CAR Close out date:Next VisitDetails of Non-Conformity: 不符合的詳細(xì)描述生產(chǎn)現(xiàn)場(chǎng)蟲(chóng)害控制管理不足GMPc

21、條款5的要求。；1）配料間沒(méi)有打開(kāi)滅蚊燈2）成品倉(cāng)一個(gè)門(mén)窗無(wú)法完全關(guān)閉。以上違反FDA CPest control management is insufficient on production site. E.g. the mosquito killer lamp being not turned on at weighing room, one window door can t be closed hemetically at warehouse. Above against the clause 5 of FDA CGMP requirement.Organization Repre

22、sentative: 公司彳表：Mr.LiangAuditor:審核員：Victor Chen; Henter HuangAction taken to eliminate the detected nonconformity: 針對(duì)不符合的糾正：Corrective Action taken to prevent recurrence:避免同樣問(wèn)題再發(fā)生的糾正措施：糾正措施：對(duì)怕滅蚊燈重新打開(kāi)使用，門(mén)窗通知設(shè)備部在3日內(nèi)進(jìn)行檢修；預(yù)防措施：1 .對(duì)現(xiàn)場(chǎng)操作及監(jiān)督人員進(jìn)行質(zhì)量衛(wèi)生和產(chǎn)品安全方面的培訓(xùn)；2.對(duì)生產(chǎn)、倉(cāng)儲(chǔ)及相關(guān)部門(mén)的滅蚊設(shè)施進(jìn)行一次排查，并糾正已發(fā)現(xiàn)的不合格項(xiàng)。Organizati

23、on Representative:Date:日期:公司彳表：Acceptance of Actions / Comments (use additional sheets if necessary)接納糾正行動(dòng) /評(píng)論評(píng)論(如有必要時(shí)使用附頁(yè)):Auditor conclusion: NC is Maintained -Q Downgraded to :- Closed審核員判定：不符合項(xiàng)口 保持-降級(jí)為：-匚|關(guān)閉Auditor:審核員Date:日期Response required (in months) 回復(fù)要求(月數(shù))Major嚴(yán)重Minor輕微Corrective Action m

24、ust be addressed within time frame stated. Verification of actionwill occur at next visit. Additional follow up may be required as indicated.糾正行動(dòng)必須于時(shí)限完成。將于下次拜訪時(shí)驗(yàn)證該行動(dòng)的果效。按顯示進(jìn)行附加跟進(jìn)。Define 確林Close Out玨Define 確認(rèn)Close Out關(guān)閉1 month3 months3不日5 days5天Next visit下次審核Corrective Action RequestCAR 5 of 5Job / C

25、ert. n : CAN15370 CN12/30930Visit Type:SurveillanceVisit n : 2Document:GP6408Issue n。：1Page n:4 of 6Organization:公司名稱(chēng)：Guangzhou Yuerong Cosmetic Co., Ltd.Site(s) audited:審核地址：No.188, Chentai Road, YongxingVillage, Longgui, Taihe Town, Baiyun District,Guangzhou, Guangdong,P.R.ChinaDate(s) of audit(s)

26、:審核日期：Auditor(s):審核員:Victor Chen; Henter HuangStandard(s):標(biāo)準(zhǔn)：US-FDA CGMPOrganization Representative:Mr.LiangArea / Department / Process:生產(chǎn) /ProductionDocument Ref.: 參考文件:GZYR10-M00-001-A0Standard Ref.:標(biāo)準(zhǔn)條款:1.eIssue/Rev. Status:版本狀態(tài)：A0CAR Close out date:Next VisitDetails of Non-Conformity: 不符合的詳細(xì)描述：外

27、包裝車(chē)間員工沒(méi)有專(zhuān)用洗手、消毒設(shè)施，以上違反FDA C GMPc條款1.e的要求。There is no specified wahing and disinfecting facility for outer packing workers in workshop.Above againstthe clause 1.e of FDA CGMP requirement.Organization Representative:Mr.LiangAuditor:審核員：Victor Chen; Henter公司彳表：HuangAction taken to eliminate the detected nonconformity:針對(duì)不符合的糾正：Correc