又一例新的CEP被吊销 EDQM 法国检查 值得警醒

有一例新的CEP被吊销。是法国在欧盟检查中观察到的缺陷：
http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPNonCompliance.do?ctrl=searchGMPNCResultControlList&action=Drilldown¶m=28493

厂家名称：浙江湖州。。。。药业
The manufacturer : HUZHOU SUNFLOWER PHARMACEUTICAL CO., LTD.

Site address :

692 North Zhiyuan Road, Wukang Town, Huzhou, Zhejiang Province, 313 200, China

产品名称： 聚维酮碘（API）缺陷内容：
共计27个缺陷项目。其中一个关键项，4个主要项目。
Nature of non-compliance : Overall, 27 deficiencies were observed, including 1 critical deficiency and 4 major deficiencies:


[Critical 1] The controlled area and the equipment that were used for the final synthesis step in the manufacture of Povidone Iodinated, namely the complexation reaction of Iodine with Povidone K30, presented a risk to the patients due to contamination issues with particles and degradation products ;


在最后的合成步骤，碘与聚维酮进行络合反应进行的洁净区与设备因为尘埃与降解物的污染问题而给患者增加风险。


[Major 1] Materials and quality documents were found at a scrap yard outside the main building of the company as well as inside the neighbouring company’s building without any written justification ;


发现一些物料与质量体系文件在一个废弃的小院里，没有任何书面解释或理由。这个小院在主办公楼之外，同时在相邻的建筑之内。
[Major 2] The purified water production and distribution systems were deficient (presence of a dead-leg, replacement of conductivity controllers without formal change control, mistakes in calibration documentation, etc.) ;
纯化水系统与分布系统存在缺陷，存在死角，电导率仪的更换未执行变更程序，验证文件有错。
[Major 3] Issuance of 2 different Certificate of Analysis in a Batch Record of Povidone K30 without an appropriate deviation management ;


在有偏差没有进行合理处理的情况下，放行了两个不同批次的COA.


[Major 4] Deficient IR spectrophotometer management (no user requirements prior to acquisition of the equipment, no evidence that the instrument was suitable with its intended use, no evidence that the instrument was belonging to the inspected site).


红外仪器管理有缺陷。设备的采购无URS，没有证据说明该仪器适用其潜在用途， 没有证据说明该仪器属于受检查的场地。


采取措施：
1. 从上市许可中去除该场地
2. 吊销CEP证书。
Action taken/proposed by the NCA :

Requested Variation of the marketing authorisation(s)
Variations of Marketing Authorisation(s) to remove the site as relevant.

Suspension or voiding of CEP (action to be taken by EDQM)
Withdrawal of CEP # 2009-166 (effective as of 19 March 2015 by the EDQM)