20140820 ECA新闻：印度无菌生产商收到FDA警告信后更名

20140820 ECA新闻：印度无菌生产商收到FDA警告信后更名  

2014-08-20 23:06:48|  分类： ECA新闻|举报|字号 [url=]订阅[/url]

原文网址：http://www.gmp-compliance.org/enews_04468_Indian-Sterile-Manufacturer-receives-FDA-Warning-Letter-and-changes-company-name-from-Marck-Biosience-to-Amanta-Healthcare.html

GMP News
20/08/2014

Indian Sterile Manufacturer receives FDA Warning Letter and changes company name from Marck Biosience to Amanta Healthcare

印度无菌生产商收到FDA警告信后将公司名称由Marck Biosience变更为Amanta Healthcare

Marck Biosciences Limited is a producer of sterile products which has been producing sterile products for the US market. It is not clear whether the company also owns an EU GMP certificate. The EudraGMDP neither lists a GMP certificate nor a GMP Non-Compliance Report. But the database is not complete yet. Still, not all countries have entered all their data into this community database.

Marck Biosciences Limited是一个无菌药品的生产商，其曾经生产无菌药品供应美国市场。不清楚该公司是否也持有EU GMP证书。EudraGDMP从未列出关于该公司的GMP证书信息，也没有过不符合GMP报告，但由于并不是所有欧盟国家均将其数据输入该数据库，因此该数据并不完整（所以无法做出判断）。

In March, the US FDA published an Import Altert for Marck Biosciences Limited, Plot No. 876, N.H. – 8, Village Hariyala, Tal Matar, Kheda 387411, India. Now, the FDA has explained why. The FDA Warning Letter dated July 8, 2014 contains shocking details about the GMP situation at this facility. Among the GMP deviations observed, the inspectors reported:

在3月份，美国FDA公布了Marck Biosciences Limited, Plot No. 876, N.H. – 8, Village Hariyala, Tal Matar, Kheda 387411, India的进口禁令。目前，FDA已解释了为什么会发布该禁令。日期为2014年7月8日的FDA警告信中包括的了关于其生产场所令人震惊的GMP状态。在GMP查获的GMP问题中，检查官报告说：

—        Inspectors found “unofficial” visual inspection records, signed by production personnel, with data that are different from the official batch records reviewed by your firm’s quality unit

—        检查员发现“非正式”目测检查记录，由生产部人员签名，其数据与你公司的质量部门审核的正式批记录不一样

—        Inspectors revealed the firm's use of scratch paper containing critical manufacturing data. The data on these scratch paper records did not always match the data on the corresponding official batch records

—        检查员发现公司使用的便笺纸中含有关键的生产数据。该便笺纸上的数据与正式的批记录上的数据不完全相符

—        At the time of the inspection, the firm hired contract employees who had not received any training on cGMP. These contract employees performed critical manufacturing operations, such as sterilizing operations. Moreover, the firm falsified documents designed to demonstrate the effectiveness of CGMP training. The production head admitted to pre-filling out the answers to post-training comprehension assessment questions and entering the names of employees on these documents.

—        在检查时，公司雇佣了合同员工，这些员工并未接受任何CGMP培训，而在执行关键的生产操作，例如无菌操作。更有甚者，公司伪造文件，用于证明CGMP培训的有效性。生产部领导承认预先填写了培训测试问题的答案，并在这些文件记录上填写上员工的姓名

—        During the inspection, investigators noted significant mold growth in the washroom located at the entry to the sterile manufacturing area. The ceiling of this room had been allowed to deteriorate to such an extent that it caved in. This room shares a common mezzanine with the adjacent sterile processing rooms.

—        在检查中，检查员注意到在无菌生产区域入口处的盥洗室内有严重的霉菌生长。该房间的天花板已腐烂形成破洞。该房间与相邻的无菌处理房处于同一个半层区域

—        The investigators noted numerous dead insects in the “Sample Pass Through” Room,  located near to the Sterile Filling Line of the small volume parenterals facility. In addition, dead and decaying frogs were found next to the product exit dock.

—        检查员注意到小容量注射剂设施中接近无菌灌装线的“样品通过”房间有大量的昆虫尸体。另外，邻近出口的地方发现腐烂的青蛙尸体

—        The investigators found numerous loose and uncontrolled labels for multiple products in the open office areaadjacent to the packaging lines. Unused labels were not stored in a manner to prevent mix-ups or mislabeling.

—        检查员在包装线隔壁的开放式办公区域内发现大量散乱不受控的多个产品标签。未使用的标签的存贮方式无法防止混淆或错误标识。

The situation observed at the Marck Biosciences can not be considered as a GMP failure only. The company did not implement basic GMP principles, and both the management and employees even falsified data to make sure that the problems will not be discovered by GMP inspectors. By doing so, they put patient safety at risk because products have been released which have not been manufactured according to GMP. Again, Indian Regulators have not identified the problems although the company had been existing for years.

在Marck Biosciences发现的缺陷情况不能仅仅作为是GMP不符合。公司显然并未遵守基本的GMP原则，管理人员和员工甚至伪造数据以防止GMP检查官发现问题。当他们这么做的时候，显然将患者的安全置于风险之下，因为其已放行的药品并未按照GMP要求生产。这次，尽管该公司的问题已存在了数年，但印度药监部门还是没有发现这些问题。

A look to the company website contains some surprising information. Just a few weeks after the US Import Alert was published the company, Marck Biosciences Ltd changed its name to Amanta Healthcare Ltd. The change became effective on June 24, 2014.

当浏览该公司网页时，其网页信息更令人惊讶。就在美国发布该公司的进口禁令后几周，Marck Biosciences Ltd将其公司名称更改为Amanta Healthcare Ltd。该变更于2014年6月24日生效。

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