化妝品GMPC審核報告--CAR

1、精品Corrective Action RequestCAR 1 of 5I | Major 匚Min orOrganization: 公司名稱:Guan gzhou Yuerong Cosmetic Co., Ltd.Site(s) audited:審核地址：No.188, Chentai Road, Yongxing Village,Lon ggui,Taihe Tow n,Baiy un District,Guan gzhou,Guan gdo ng, P .R.Ch inaDate(s)ofaudit(s):審核日期：Auditor(s):審核員：Victor Chen; Hen te

2、r HuangStandard(s):標(biāo)準(zhǔn)：US-FDA CGMPOrga ni zati onReprese ntative:ng 波先.Area /Departme nt/Process:生產(chǎn)Docume nt Ref.:參考文件：GZYR02-M04-001-A0Sta ndardRef.: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 No n-Co nformity:不符合的詳細(xì)描述:基礎(chǔ)設(shè)施管理維護(hù)不足，如：1 潔凈車間內(nèi)半成品存貯間1-2樓板有一個空調(diào)孔洞；2

3、潔凈車間風(fēng)淋室入口感應(yīng)系統(tǒng)不能準(zhǔn)確控制門禁開合；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 productsstorage room , and the air shower' s entries door control system is out of accurancy . Above against theclause 1 of FDA CGMP requirement.Orga ni zat

4、i onRepresentative:公司代表：Mr.Lia ngAuditor:審核員：Victor Chen; HenterHuangActio n take n to elimi nate the detected noncon formity:針對不符合的纟糾正：Corrective Actio n taken to prevent recurre nee:避免同樣問題再發(fā)生的糾正措施：糾正措施：通知設(shè)備部人員3日內(nèi)對空調(diào)孔洞進(jìn)行修補(bǔ)，15日內(nèi)完成對風(fēng)淋間入口感應(yīng)的調(diào)整。預(yù)防措施：針對以上硬件不合格項，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。Orga ni zati o

5、n Represe ntative: 公司代表：Date:日期：Accepta nee of Actio ns / Comme nts(use additional sheets if necessary) :接納糾正行動 / 評論評論(如有必要時使用附頁):Auditor con clusi on:NC is審核員判定：不符合項Mai ntained-保持-Down graded to :-降級為：-Closed口關(guān)閉Auditor:審核員Date:日期Resp onse required (in mon ths)回復(fù)要求(月數(shù))Major嚴(yán)重Minor輕微Corrective Action

6、 must be addressed within time frame stated. Verification ofDefine 確Close OutDefi neClose Outaction will occur at next visit. Additional follow up may be required as indicated._認(rèn)關(guān)閉確認(rèn)關(guān)閉糾正行動必須于時限完成。將于下次拜訪時驗證該行動的果效。按顯示進(jìn)行附加跟進(jìn)。1 mon th1個月3 mon ths3個月5 days5天Next visit下次審核Corrective Action RequestCAR 2 of

7、 I I Major 匚Min orOrganization: 公司名稱:Guan gzhou Yuerong Cosmetic Co., Ltd.Site(s) audited:審核地址：No.188, Chentai Road, Yongxing Village,Lon ggui,Taihe Tow n,Baiy un District,Guan gzhou,Guan gdo ng, P .R.Ch inaDate(s)ofaudit(s):審核日期：Auditor(s):審核員：Victor Chen; Hen ter HuangStandard(s):標(biāo)準(zhǔn)：US-FDA CGMPOrg

8、a ni zati onReprese ntative:ng 波先.Area /Departme nt/Process:生產(chǎn) /ProductionDocume nt Ref.:參考文件：GZYR02-M04-006-A0Sta ndardRef.:標(biāo)準(zhǔn)條款：5.cIssue/Rev. Status:版本狀 態(tài)：A0CAR Close out date:Next VisitDetails of No n-Co nformity:不符合的詳細(xì)描述：生產(chǎn)現(xiàn)場使用的分裝消毒液和消毒液存貯桶沒有明確標(biāo)識；生產(chǎn)設(shè)備清潔消毒管理制度文件編號GZYR-06-M06-012-A0 ,沒有規(guī)定使用的清洗劑及消毒

9、劑品種；以上違反FDA C GMPc條款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. Aboveagainst the clause 5.c of FDA CGMP requirement.Orga ni zati onRepres

10、entative:公司代表:Mr.Lia ngAuditor:審核員：Victor Che n;Hen ter HuangActio n take n to elimi nate the detected noncon formity:針對不符合的纟糾正：Corrective Actio n taken to prevent recurre nee:避免同樣問題再發(fā)生的糾正措施：糾正措施：重新修訂GZYR- 06 - M06 - 12 - A0的管理制度文件，并按要求對現(xiàn)場的消毒液進(jìn)行分類品種進(jìn)行標(biāo)識。預(yù)防措施：對操作現(xiàn)場的標(biāo)識重新進(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

11、及 用法。Orga ni zati on Represe ntative: 公司代表：Date:日期：Organization Representative:Date: 日期：Accepta nee of Actio ns / Comme nts(use additional sheets if necessary):接納糾正行動 / 評論評論 (如有必要時使用附頁):Auditor con clusi on:NC is審核員判定：不符合項匚Mai ntained保持-Down graded to :-Closed降級為：-關(guān)閉Auditor:審核員Date:日期公司代表：Resp onse

12、required (in mon ths)回復(fù)要求(月數(shù))Major嚴(yán)重Minor輕微Corrective Action must be addressed within time frame stated. Verification ofDefine 確Close OutDefi neClose Outaction will occur at next visit. Additional follow up may be required as indicated.認(rèn)關(guān)閉確認(rèn)關(guān)閉糾正行動必須于時限完成。將于下次拜訪時驗證該行動的果效。按顯示進(jìn)行附加跟進(jìn)。3 mon ths5 days5天Ne

13、x t visi t1個月下次審核orrective Action Req uestCAR 3 of 5I I Major|_Minor愛Organization: 公司名稱：Guan gzhou Yuerong Cosmetic Co., Ltd.Site(s) audited:審核地址：No.188, Chentai Road, Yongxing Village,Lon ggui,Taihe Tow n,Baiy un District,Guan gzhou,Guan gdo ng, P .R.Ch inaDate(s)ofaudit(s):審核日期：Auditor(s):審核員：Vict

14、or Chen; Hen ter HuangStandard(s):標(biāo)準(zhǔn)：US-FDA CGMPOrga ni zati onReprese ntative:ng 梁波先生Area /Departme nt/Process:生產(chǎn) /ProductionDocume nt Ref.:參考文件：GZYR02-M04-017-A0Sta ndardRef.:標(biāo)準(zhǔn)條款：5.aIssue/Rev. Status:版本狀 態(tài)：AOCAR Close out date:Next VisitActio n take n to elimi nate the detected noncon formity:針對不

15、符合的纟糾正：Corrective Actio n taken to prevent recurre nee:避免同樣問題再發(fā)生的糾正措施：糾正措施：對較受污染的半成品料休進(jìn)仃重新檢測，待確疋合格后再進(jìn)仃下工序生產(chǎn)；預(yù)防措施：由生產(chǎn)部組織相關(guān)人員進(jìn)行清場制度的強(qiáng)化培訓(xùn)，讓操作人員清晰地了解并貫徹清場制度。Orga ni zati on Represe ntative: 公司代表：Date:日期：Organization Representative:Date: 日期：Accepta nee of Actio ns / Comme nts(use additional sheets if nec

16、essary):接納糾正行動 / 評論評論 (如有必要時使用附頁):Auditor con clusi on:NC is審核員判定：不符合項匚Mai ntained保持-Down graded to :-| | Closed降級為：-關(guān)閉Auditor:審核員Date:日期公司代表：Details of No n-Co nformity:不符合的詳細(xì)描述:審核現(xiàn)場罐裝產(chǎn)品批 WS170701因突發(fā)停電，清場時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 大周轉(zhuǎn)桶，存在批產(chǎn)品污染風(fēng)險；以上違反FDA C GMPc條款5.a的要求。When final products lot No.WS17

17、0701is filling, the power cut incident happen in audit site. Thefilli ng staff pour the residual products of bala nee bottle into the bulk products bucket, maybe bulkproducts polluti on risk.Above against the clause 5.a of FDA CGMP requirement.Orga ni zati onRepresentative:公司代表：Mr.Lia ngAuditor:審核員：

18、Victor Che n;Hen ter HuangResp onse required (in mon ths)回復(fù)要求(月數(shù))Major嚴(yán)重Min or輕微Corrective Action must be addressed within time frame stated. Verification ofaction will occur at next visit. Additional follow up may be required as indicated. 糾正行動必須于時限完成。將于下次拜訪時驗證該行動的果效。按顯示進(jìn)行附加跟進(jìn)。Define 確認(rèn)Close Out關(guān)閉關(guān)

19、閉Defi ne確認(rèn)Close Out關(guān)閉1 mon th3 mon ths3個月5 days5天Next visit下次審核Corrective Action RequestCAR 4 of 5MinorOrganization: 公司名稱:Guan gzhou Yuerong Cosmetic Co., Ltd.Site(s) audited:審核地址：No.188, Chentai Road, Yongxing Village,Lon ggui,Taihe Tow n,Baiy un District,Guan gzhou,Guan gdo ng, P .R.Ch inaDate(s)o

20、faudit(s):審核日期：Auditor(s):審核員：Victor Chen; Hen ter HuangStandard(s):標(biāo)準(zhǔn)：US-FDA CGMPOrga ni zati onReprese ntative:ng 梁波先生Area /Departme nt/Process:生產(chǎn) /ProductionDocume nt Ref.:參考文件：GZYR10-M00-001-A0Sta ndardRef.:標(biāo)準(zhǔn)條款：5Issue/Rev. Status:版本狀 態(tài)：A0CAR Close out date:Next VisitDetails of No n-Co nformity:

21、不符合的詳細(xì)描述:生產(chǎn)現(xiàn)場蟲害控制管理不足配料間沒有打開滅蚊燈2)成品倉一個門窗無法完全關(guān)閉。以上違反FDA CGMPc條款5的要求。Pest con trol man ageme nt is in sufficie nt on producti on site. E.g. the mosquito killer lamp being nottur ned on at weighi ng room, one wi ndow door can' t be closed hemetically at warehcAlseveagainst the clause 5 of FDA CGMP

22、requirement.Orga ni zati onRepresentative:公司代表：Mr.Lia ngAuditor:審核員：Victor Che n;Hen ter HuangActio n take n to elimi nate the detected noncon formity:針對不符合的纟糾正：Corrective Actio n taken to prevent recurre nee:避免同樣問題再發(fā)生的糾正措施：糾正措施：對怕滅蚊燈重新打開使用，門窗通知設(shè)備部在3日內(nèi)進(jìn)行檢修；預(yù)防措施：1 .對現(xiàn)場操作及監(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.對生產(chǎn)、倉儲

23、及相關(guān)部門的滅蚊設(shè)施進(jìn)行一次排查，并糾正已發(fā)現(xiàn)的不合格項。Orga ni zati on Represe ntative: 公司代表：Date:日期：Accepta nee of Actio ns / Comme nts(use additional sheets if necessary):接納糾正行動 / 評論評論(如有必要時使用附頁):Auditor con clusi on:NC is審核員判定：不符合項匚Mai ntained保持-Down graded to :-Closed降級為：-關(guān)閉Auditor:審核員Date:日期Resp onse required (in mon th

24、s)回復(fù)要求(月數(shù))Major嚴(yán)重Minor輕微Corrective Action must be addressed within time frame stated. Verification ofDefine 確Close OutDefi neClose Outaction will occur at next visit. Additional follow up may be required as indicated.認(rèn)關(guān)閉確認(rèn)關(guān)閉糾正行動必須于時限完成。將于下次拜訪時驗證該行動的果效。按顯示進(jìn)行附加跟進(jìn)。1 month3 months5 days5天Next visit1個日3個

25、月下次審核Corrective Action RequestCAR 5 of 5MinorOrganization: 公司名稱：Guan gzhou Yuerong Cosmetic Co., Ltd.Site(s) audited:審核地址：No.188, Chentai Road, Yongxing Village,Lon ggui,Taihe Tow n,Baiy un District,Guan gzhou,Guan gdo ng, P .R.Ch inaDate(s)ofaudit(s):審核日期：Auditor(s):審核員：Victor Chen; Hen ter HuangSt

26、andard(s):標(biāo)準(zhǔn)：US-FDA CGMPOrga ni zati onReprese ntative:ng 梁波先生Area /Departme nt/Process:生產(chǎn) /ProductionDocume nt Ref.:參考文GZYR10-M00-001-Sta ndardRef.: 標(biāo)準(zhǔn)條 1.e件：A0款：Issue/Rev. Status:版本狀 態(tài)：A0CAR Close out date:Next VisitDetails of No n-Co nformity:不符合的詳細(xì)描述:外包裝車間員工沒有專用洗手、消毒設(shè)施，以上違反FDA C GMPc條款1.e的要求。There is no specified wahi ng and dis in fect ing facility for outer pack ing workers in workshop.Aboveagainst the clause 1.e of FDA CGMP req