法国药监（ANSM）公布与霉菌有关的不符合性报告

20150826 ECA新闻：法国药监（ANSM）公布与霉菌有关的不符合性报告  

GMP News
26/08/2015
French Authority (ANSM) published statement of non-compliance related to mould contaminations
法国药监（ANSM）公布与霉菌有关的不符合性报告
In June, TxCell has shut down their manufacturing facility in Besan?on, but the reason was not published. The site manufactures aseptically prepared small volume liquids. The products are personalized T cellimmunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases.
在6月，TXCELL关闭了其在BESANCON的生产工厂，但关闭原因并没有公布。该工厂生产无菌小容量注射液。药品为使用抗原T细胞（AG-TREGS）的个性化T细胞免疫疗法，用于严重慢性炎症和自身免疫疾病。
Now, the French National Agency for Medicines and Health Products Safety (ANSM) released the inspection report. The ANSM summarized the nature of non-compliance as follows:
日前法国药监（ANSM）公布了检查报告，其中汇总了不符合项如下：
"Overall, 22 deficiencies were observed, including 7 major deficiencies on the following topics:
共发现22项缺陷，其中7个为主要缺陷，是关于以下主题的：
1. The pharmaceutical quality system was deficient as several deviations opened during the period 2014-2015 were overdue and still pending. Namely, 43 non conformities were related to environmental deviations of which 30 were related to mould contamination during production of investigational batches and Media Process Test. Moreover, some investigational product batches were released whereas deviations cases were still open.
药品质量体系有缺陷，2014-2015年期间有多个偏差未关闭。换句话说，43项与环境偏差有关的不符合结果，其中30个与临床前批次和培养基工艺测试的生产过程中的霉菌污染有关。另外，有些临床前批次在偏差还未关闭时即已放行。
2. Paper batch records and labels required in aseptic areas were not sterilised or passed into the area by a procedure which achieves the same objective of not introducing contamination.
无菌区域的纸质批记录和标签未灭菌，或通过控制程序传递进入无菌区来保证不引入污染。
3. Appropriate alert limits were not set for the results of microbiological monitoring of clean rooms."
洁净区微生物监测结果没有设定适当的警戒限。
TXCells is currently working on improvements of the pilot site and expects to complete the necessary activities and to get reapproved until end of 2015. In the meantime, the manufacturing of the clinical batches was outsourced to a CMO.
EXCELLS现在正在努力改善其中试工厂状况，期望能完成必要的措施，到2015年底重新获得批准。其临床批次的生产已外包给一个CMO。
More details can be found in the ANSM report as well as in the TxCell press release.
更多信息可以在上述ANSM官网和TXCELL新闻网站找到。

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