印度和中国API生产商受到欧洲药监关注

20150805 ECA新闻：印度和中国API生产商受到欧洲药监关注  
GMP News
05/08/2015
Indian and Chinese API Manufacturers in the Focus of European Authorities
印度和中国API生产商受到欧洲药监关注
The EudraGMP database was originally launched in April 2007 and is used to exchange information on compliance with the Good Manufacturing Practices (GMP) between the relevant regulatory authorities of the EU Member States - including Iceland, Liechtenstein and Norway. Since January 2011 the data of all national authorities can be accessed. Further, since April 2013 the database also contains information about GDP, why it is referred to as Eudra GMDP database now.
欧洲EUDRAGMP数据库最初在2007年发起，是用于欧盟成员国相关药监机构---包括冰岛、列支敦士克和挪威---之间交换GMP符合性信息的。从2011年1月开始，所有国家药监局的数据都可以查阅。自2013年4月开始，数据库也包括了关于GDP的信息，这也就是为什么现在这个数据库被称为EUDRA GMDP数据库的原因。
The database comprising the reports about deficiencies found in inspections by the European authorities - the "non-compliance reports" or, officially, "statement of non-compliance with GMP" - was extended by three reports last week: two of these reports related to Chinese firms, one report to a company in India. The inspections were conducted by inspectors of the Italian authority.
数据库包括了欧洲药监局在检查中发现的缺陷报告----“不符合情况报告”或，正式的“不符合GMP声明”---在上周这个数量又扩大了：2个与中国公司有关，一个是印度公司的。检查是由意大利药监局进行的。
The inspection of the Indian site (antibiotic APIs) revealed that samples, materials and documents were stored improperly. The falsification of data and documents was found. At one of the two Chinese manufacturers who also produces an antibiotic API, inspectors were also not allowed to access an apparently uncontrolled storage area of raw material and finished products - which they estimated as high risk in terms of data falsification. In the second inspected Chinese manufacturing facility (sterile active ingredient manufacture) inspectors objected to especially high risks with regard to contamination (inadequate clothing of workers, no monitoring of the differential pressure between spaces of different purity classes, no precautions to avoid contamination during the transfer of the sterile active substance between different containers etc.).
印度工厂的检查（抗生素原料药）发现样品、原料和文件存贮不适当。发现数据和文件造假。在2个中国生产商中的1个也是生产抗生素原料药的工厂里，检查员也是未被允许进入一个显然是不受控的原料和成品存贮区域-----他们评估为高风险数据造假。在检查的第二个中国工厂里（无菌活性成分生产），检查员认为该工厂污染风险太高（工厂更衣不充分、不同洁净区空间压差没有监测、将无菌活性物质在不同容器间转移时没有防止污染的预防措施等）。
As a consequence of the inspection results, the competent authorities were prompted to check in all three cases whether the manufacturer must be removed from the relevant registration documents. In this case, the marketing authorisation holders have to look for alternative API suppliers. Furthermore, the regulatory authorities are urged not to approve new applications in which these manufacturers are listed. The corresponding CEPs for the Indian and for one of the Chinese manufacturers were suspended respectively withdrawn.
由于不符合性检查结果，药监当局要检查所有三例中的生产商是否需要从其相关的注册文件中去除。如果是这样，则上市许可持有人不得不寻求替代的原料药供应商。另外，法规当局将不会批准列入这几个生产商的新的申报。印度生产商和其中一个中国生产商相应的CEP已相应地被撤销。
The Eudra GMDP database so far contains a total of 7 non-compliance reports on inspections at API manufacturers in China (3), India (2), United States (1) and the United Kingdom (1).
EUDRA GMDP数据库到目前为止包括总共 7个不符合报告，3个在中国，2个在印度，2个在美国，1个在英国。
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