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本帖最后由 皇后 于 2016-4-1 07:51 编辑
本文转自康利华咨询订阅号，原文链接
http://mp.weixin.qq.com/s?__biz=MzA4NDA1MDEzNA==&mid=4062790509&idx=1&sn=a4eb41940d6ba126170738145ba16bf8&scene=1&srcid=0331LwDYpYAf0DpYlEHURA8Q#wechat_redirect
【康利华导读】
最近，印度一药企在EUGMP检查中，因为一个关键缺陷和两个主要缺陷没有通过现场检查，在缺陷正文中提到了一个中国制药企业，躺着中枪。
【缺陷翻译】
Overall, 24 deficiencies were observed during theinspection, 1 Critical and 2 Major deficiencies: * * *
在检查中共发现了24个缺陷项，其中包括1个关键缺陷和2个主要缺陷。
[Critical 1]
No transfer of information to the user ofthe active substance as regards to the original manufacturers of the activesubstances only micronized at the site (i.e. manufacturer name, original batchnumber and COA) and exported to Europe or that may be sold to distributors exporting to Europe. The following active substances were micronized from othersources (as communicated by the company - may not be exhaustive): Azithromycin,Chloramphenicol, Chloramphenicol Palmitate, Ciprofloxacin HCl, Clarithromycin,Piperaquine phosphate, Roxithromycin and Sulfadoxine. Moreover, a non EU-GMPcompliant source for Azithromycin (NCF/010/RO, Hebei Dongfeng PharmaceuticalCo., Ltd, China) was micronized and directly exported to Europe under themanufacturer name Anuh Pharma. * * *
[关键缺陷1]
仅微粉工序在工厂进行的活性物质的原始生产商信息（如生产商名称、原始批号及CoA）未传递给使用者，并且这些物料直接出口到了欧洲或者出售给了出口到欧洲的贸易商。以下这些被微粉的物料来自于其他来源（根据与公司的沟通，可能不详尽）：阿奇霉素，氯霉素，棕榈氯霉素、盐酸环丙沙星、罗红霉素、克拉霉素、磷酸哌喹，磺胺多辛。同时，一个不符合EU-GMP来源的叠氮红霉素（NFC/010/RO,河北东风制药有限公司，中国）被微粉粉碎后直接出口到了欧洲的制药商Anuh Pharma.
[Major 1]
Deficiencies in documentation management.Several documents were found within a pile of rubble on the other side of awall. These included an original batch repacking record which should have beenplaced under retention and a large number of purchase orders dated from 2013for active substances, notably Azithromycin, Chloramphenicol, ChloramphenicolPalmitate, Roxithromycin and Ciprofloxacin HCl. * * *
[主要缺陷1]
在文件管理方面存在缺陷。在墙的另外一侧的瓦砾中发现了一些文件。这些文件包括一个本应该被良好保存的重包装原始批记录，以及大量自2013年开始的活性物质采购订单，特别是阿奇霉素，氯霉素，氯霉素棕榈酸酯、罗红霉素和盐酸环丙沙星。
[Major 2]
Deficiencies in process validation. Novalidation data was available for the blending of micronized batches. Nocleaning validation was available for one air jet mill used for micronization.No supporting data for the reduced testing of the recovered Ethyl Acetatesolvent was available.
[主要缺陷2]
工艺验证方面存在缺陷。微粉批次的混合没有可用的验证数据。用于微粉的气流粉碎机没有进行适当的清洁验证。没有可用的数据支持回收乙酸乙酯的减少测试（可能是隔批检验或者减少检验项目，译者注）。
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发表于 2016-3-31 11:35:40
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