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EudraGMDP不合规数据库又多一家中国湖州的制药公司
这是0325签发的一份报告
由法国药监部门检查、公布
不合格企业是中国湖州的一家原料公司,生产的是非无菌原料药
缺陷内容如下:
总共有27条缺陷,包括1条严重缺陷和4条主要缺陷。
严重缺陷:在生产Povidone Iodinated的最后的合成步骤即Iodine与Povidone K30络合反应所处的控制区域和设备,由于粒子和产品降解物质的污染问题可能对病人产生风险;
主要缺陷1:物料和质量文件被发现在公司主楼外的垃圾场中,也存在于附近公司的建筑中,而且没有任何书面合理说明;
主要缺陷2:纯化水生产和分配系统存在缺陷(表现为有死角、更换电导率控制装置时没有正式变更、校准文件有错误等);
主要缺陷3:Povidone K30的批记录中分发了2份不同的CoA,没有适当的偏差管理;
主要缺陷4:IR色谱管理存在缺陷(没有对使用用户进行要求,没有证据说明设备能够满足预期用途,没有证据证明设备属于被检查场地)。
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 ; [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 ; [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.) ; [Major 3] Issuance of 2 different Certificate of Analysis in a Batch Record of Povidone K30 without an appropriate deviation management ; [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).
http://eudragmdp.ema.europa.eu/i ... own¶m=28493
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