201504 湖州某药企欧盟检查失败

201504 湖州某药企欧盟检查失败  

2015-04-03 09:10:53|  分类： EU GMP

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来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720153391053397/

受检企业：HUZHOU SUNFLOWER PHARMACEUTICAL CO., LTD.

检查官方：法国药监

检查日期：2015-1-30

结果上网日期：2015-4-3

Nature of non-compliance : Overall, 27 deficiencies were observed, including 1 critical deficiency and 4 major deficiencies:

总共发现27条缺陷，包括1个关键项和4个主要项：

[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 ;

【关键1】聚维酮（碘化）最终合成步骤使用的控制区域和设备，也就是碘与聚维酮K30的复合反应，因为有被颗粒物和降解产物污染的问题引起患者风险。

[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 ;

【主要1】在公司主建筑之外的废弃场，以及邻近公司的建筑物内发现了物料和质量文件，且没有书面论证。

[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.) ;

【主要2】纯化水生产和分配系统有缺陷（死管、电导率控制器的替换没有正式的变更控制，校正文件错误等）

[Major 3] Issuance of 2 different Certificate of Analysis in a Batch Record of Povidone K30 without an appropriate deviation management ;

【主要3】在聚维酮K30的批生记录里有2份不同的分析报告（COA），且没有适当的偏差管理。

[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).

【主要4】红外光谱管理有缺陷（在设备请购之前没有用户要求，无证据证明该仪器适用于既定用途，没有证据证明仪器属于该受检场所）。

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)

建议措施：要求其客户对上市许可进行变更，对CEP # 2009-166（生效日期2015年3月19日）进行搁置或撤销

CEP # 2009-166 was originally suspended on 21 June 2012 by the EDQM following the refusal of a scheduled inspection.

其CEP曾在2012年6月21日因为拒绝检查被EDQM搁置。

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