美国FDA发出警告函的API设施

清歌一曲月如霜

FDA issues Warning Letter for API Facility

美国FDA已发出警告信，天津中安药业有限公司在天津，中国。本公司生产的API，未能在该设施建立适当的GMP规范。
在相当一段时间印度是人们关注的焦点，很少听到有关中国GMP的问题（参见RAPS文章）。这是一个有点令人惊讶，因为一些不符合标准的设施，在过去被检测到。也造成了肝素丑闻设施均位于中国。来自美国FDA的最后执法行动，成为公共简称进口警报的制造商浙江九洲药业和浙江Zonebanne在中国。
新的警告信天津中安药业列出了一些不同的非合规的调查结果。这些发现是指设备清洗（交叉污染的风险），没有足够的变更控制程序，并未能充分审查和调查产品的偏差。然而，在差异最近向印度制造商的警告信的数据完整性问题都没有被侦破。
有趣的是，API生产商天津中安药业未在EudraGMDP检查数据库在欧盟上市。对于GMP认证或GMP违规举报没有条目可用。
资料来源：FDA的警告信到天津中安药业

The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China. The company produces APIs and failed to establish adequate GMP procedures at the facility.
For quite some time India was in the center of attention and very little was heard about GMP problems in China (see also RAPS article). This is a bit surprising because a number of non-compliant facilities have been detected in the past. Also the facilities which caused the Heparin Scandal were located in China. The last enforcement action from FDA which became public referred to Import Alerts for the manufacturer Zhejiang Jiuzhou Pharmaceutical and for Zhejiang Zonebanne in China.
The new Warning Letter for Tianjin Zhongan Pharmaceutical lists a number of different non compliance findings. These findings refer to equipment cleaning (risk of cross contamination), not adequate Change Control procedures and failure to adequately review and investigate product deviations. However, in difference to the Warning Letters sent to Indian manufacturers recently data integrity issues have not been detected.
Interestingly the API manufacturer Tianjin Zhongan Pharmaceutical is not listed in EudraGMDP the inspection database in the EU. No entry for GMP Certificates or GMP Non-Compliance Report are available.
Source: FDA Warning Letter to Tianjin Zhongan Pharmaceutical

小李飞刀

学习一下。

syhorchid

又一洋泾浜：FDA Warning Letter to Tianjin Zhongan Pharmaceutical. FDA的警告信到天津中安药业。

一沙一叶

还是要自己看英语啊