印度药品生产商不符合报告：交叉污染

一沙一叶

Non-Compliance by Indian Drug Manufacturer: Cross Contamination
印度药品生产商不符合报告：交叉污染

So-called Non-Compliance reports are summaries of inspections conducted by European inspectors. They are publicly available on the EMA’s (European Medicines Agency) website. In the present case, the Non-Compliance Report is based on the inspection of an Indian pharmaceutical manufacturer in Bangalore, which was conducted by the MHRA in November 2017.
所谓不符合报告是欧盟检查员实施检查之后的总结。他们公开发布在EMA的网站上。最近，有一份针对印度班加洛尔的药品生产商检查的不符合报告发布，是在英国药监MHRA于2017年11月检查之后发布的。
The report concerns the manufacturing of non-sterile dosage forms: tablets and capsules as well as their primary and secondary packaging. The inspectors found the cleaning procedure and the proof of cleaning success during product changes to be inadequate. As a result of the inspection, the GMP certificate was withdrawn. Due to the severity of the deficiencies found and the resulting cross contamination risk, the MHRA recommends a precautionary recall of all affected batches in the market.
该报告是关于非无菌制剂生产的：片剂和胶囊及其内包和外包操作。检查员发现更换产品的清河程序及清洁成功的证据不是充分的，因此在检查之后，该生产商GMP证书被撤回。由于所发现缺陷的严重性及其导致的交叉污染风险，MHRA建议其作为预防措施召回市场上所有受影响批次。
Source: EudraGMDP Database
来源：欧盟GMDP数据库

whqiang78

没做验证还是怎么了？

hsu2715

這只是冰山一角.............

syhorchid

交叉污染，不容忽视。

酷哥

存在交叉污染风险，后果很严重