20141001 ECA新闻：欧盟检查河北东风发现26个缺陷

20141001 ECA新闻：欧盟检查河北东风发现26个缺陷  

2014-10-10 13:06:32|  分类： ECA新闻|

GMP News
01/10/2014

EU GMP Inspectors find 26 GMP Deficiencies at Chinese API Manufacturer Hebei Dongfeng Pharmaceuticals

欧盟GMP检查员在中国原料药生产商河北东风药业有限公司发现26个缺陷

EU GMP Inspectors from the competent authority in Romania identified several GMP deviations during a GMP inspection at HEBEI DONGFENG PHARMACEUTICAL Co., Ltd, Mingjiao Road Western Yongnian County, Handan, 057 150, China. As a consequence, a GMP Non-Compliance Report has been issued and entered into the European database EudraGMDP.

罗马尼亚的欧盟GMP检查员在河北东风药业有限公司GMP检查中发现多个GMP缺陷，并因此签发了GMP不符合报告，公布在EUDRAGMDP数据库中。

The products concerned are doxycycline hyclate and doxycycline monohydrate. According to EudraGMDP, a total of 26 deficiencies were found during the inspection. Six of them were rated as major:

受影响产品有海克多西环素和多西环素一水合物。根据EUDRAGMDP数据库，检查期间共发现26个缺陷，其中6个被判定为主要缺陷：

1.      未完全实施质量保证体系

2.      关于文件管理问题

3.      与物料管理和合格供应商资质的偏差

4.      生产区域污染风险

5.      检测样品污染和交叉污染风险

6.      QC化验室的数据记录和数据完整性不符合要求

1) not fully implemented Quality Assurance system
2) problems related to the documentation management
3) deviation related to material management and qualification of the approved supplier
4) risk of contamination in the production area
5) risk of contamination and cross-contamination of testing samples
6) data recording and integrity in the QC laboratory not in compliance

It is very interesting to see that for the first time the GMP Non-compliance Reportalso lists known customers of the API manufacturer. The report states: "Known customers Doxycycline hyclate: Sintofarm, Industria, P.S.P. ,Chemifarma, Zetercoop Italy; Ofichem, ORFFA, ALC Netherlands; Divasa Spain; Wins Czech Republik, Remedica Cyprus, Farmabase Brasil, many others in rest of the world. Doxycycline monohydrate: only local market. Finished dosage forms: only local market"

有意思的是这是第一次在GMP不符合性报告中列出了该原料药生产商的已知客户的名称。报告尔“已知海克多西环素客户：Sintofarm, Industria, P.S.P. ,Chemifarma, Zetercoop Italy; Ofichem, ORFFA, ALC Netherlands; Divasa Spain; Wins Czech Republik, Remedica Cyprus, Farmabase Brasil, 以及世界其它地区。多西环素一水合物：只有当地市场。制剂：只有当地市场”。

European manufacturers of medicinal products are not allowed to use the APIs concerned from Hebei Dongfeng Pharmaceuticals.

欧盟制剂生产商不可以再使用河北东风药业的相关原料药。

Source: EudraGMDP

http://zhuyujiao1972.blog.163.com/blog/static/9869472720149101632287/

感谢楼主分享，辛苦