1 极简GMP 详细介绍
2 美国cGMP 详细介绍
3.欧盟GMP 详细介绍
4.WHO-GMP 详细介绍
5.日本GMP 详细介绍
6 PIC/S-GMP 详细介绍
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不符合项：
This non conformity concerns the manufacture of amphotericine B powder for dispersion only. During the inspection of Yung Shin Pharmaceutical Industry Co. Ltd., there were 2 major concerns:
The sterility of the drug cannot be guaranteed,
不能保证药品的无菌性； The risks of cross-contamination are insufficiently known and managed.
对交叉污染的风险认识和管理不足。
In relation to the aseptic process: The firm accumulates several deficiencies related to the aseptic processing, for instance：
It does not correctly address the filling line set up assembly (lack of aseptic connectors and aseptic sampling port),
它没有正确解决灌装线组装（缺乏无菌连接器和无菌取样口）； Nor the particular configuration of the booth housing the filling tank (first air concept not taken into account).
也没有考虑放置灌装罐的层流罩的特殊配置（没有考虑首过空气概念）； In addition, the aseptic process simulation needs to be improved as well as the sterilization of : materials, filling lines and equipments.
此外，无菌工艺模拟以及物料、灌装线和设备的灭菌有待改进； None of these elements are assessed in the CCS (Contamination Control Strategy).
这些要素在CCS（污染控制策略）中都没有得到评估。
In relation to cross-contamination, it was found that the plant also manufactures other drugs including corticoids. However, the ADE values of the APIs are not known, a risk analysis of the cross-contamination risks and a cross-contamination prevention strategy based on it are missing.
比利时药监局采取/建议的行动:
Amphotericin B manufactured at Yung Shin Pharmaceutical Industry Co. Ltd.is currently not imported to the EU market and the site does not hold a MIA nor a GMP certificate. No action is required.
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