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[FDA药事] 印度人真够“聪明”

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药徒
发表于 2014-8-21 09:43:45 | 显示全部楼层 |阅读模式

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Indian Sterile Manufacturer receives FDA Warning Letter and changes company name from Marck Biosience to Amanta Healthcare
  Sterile Manufacturer receives FDA Warning Letter and changes company name from Marck Biosience to 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. In March, the US FDA published an Inport 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:
- 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
- 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
- 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.
- 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.
- 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.
- The investigators found numerous loose and uncontrolled labels for multiple products in the open office area adjacent to the packaging lines. Unused labels were not stored in a manner to prevent mix-ups or mislabeling.
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.
A look to the company website contains some surpring 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,
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大师
发表于 2014-8-21 10:07:51 | 显示全部楼层
有想法。。
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药徒
发表于 2014-8-21 09:47:10 | 显示全部楼层
阿三好可爱啊
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发表于 2014-8-21 09:59:33 | 显示全部楼层
笨蛋的天才想法!
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药徒
发表于 2014-8-21 10:07:41 | 显示全部楼层
英文不好真是太痛苦了……看不懂啊……

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这个julia翻译了啊,我早上还看过谁发的帖子来着,这家伙被警告了,美国禁止其出口,然后自己把名字改了,哈哈,糊弄美国想,结果被发现了  详情 回复 发表于 2014-8-21 12:18
同感。不好意思。  详情 回复 发表于 2014-8-21 10:13
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药徒
发表于 2014-8-21 10:13:02 | 显示全部楼层
左司马 发表于 2014-8-21 10:07
英文不好真是太痛苦了……看不懂啊……

同感。不好意思。

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矣,学好英文,很有必要!!!  详情 回复 发表于 2014-8-21 10:26
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药生
发表于 2014-8-21 10:25:02 | 显示全部楼层
左司马 发表于 2014-8-21 10:07
英文不好真是太痛苦了……看不懂啊……

同感,
用了有道还是解决不了啊……

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学好英文,很有必要……  发表于 2014-8-21 10:26
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药徒
发表于 2014-8-21 10:26:15 | 显示全部楼层
怀谷 发表于 2014-8-21 10:13
同感。不好意思。

矣,学好英文,很有必要!!!

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言之有理!  详情 回复 发表于 2014-8-22 10:12
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药徒
发表于 2014-8-21 10:42:45 | 显示全部楼层
奇葩的阿三哥。逗比啊。
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药徒
发表于 2014-8-21 11:21:09 | 显示全部楼层
改名换姓。。。。。。。
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药徒
发表于 2014-8-21 11:58:21 | 显示全部楼层
有思想。以为这就查不出来了吗?
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药生
发表于 2014-8-21 12:18:18 | 显示全部楼层
左司马 发表于 2014-8-21 10:07
英文不好真是太痛苦了……看不懂啊……

这个julia翻译了啊,我早上还看过谁发的帖子来着,这家伙被警告了,美国禁止其出口,然后自己把名字改了,哈哈,糊弄美国想,结果被发现了

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哦,果然是比较有才的阿三……  发表于 2014-8-21 13:02
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发表于 2014-8-21 13:22:06 | 显示全部楼层
再警告,就改地址。
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药生
发表于 2014-8-21 13:33:20 | 显示全部楼层
左司马 发表于 2014-8-21 10:26
矣,学好英文,很有必要!!!

对对……

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现在还来得及。  发表于 2014-8-21 13:52
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药徒
发表于 2014-8-21 13:34:05 | 显示全部楼层
也属于看不懂
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药士
发表于 2014-8-21 13:45:46 | 显示全部楼层
scratch paper、 contract employee not received any training on cGMP、falsified documents、 significant mold growth 、The ceiling of this room   caved in、 numerous dead insects、dead and decaying frogs、 loose and uncontrolled labels、change the name,这样的企业,枪毙算了!!!!
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药徒
发表于 2014-8-21 19:42:20 | 显示全部楼层
这算掩耳盗铃 ?鸵鸟伏沙? 阿三思维真发散
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药生
发表于 2014-8-21 20:12:10 来自手机 | 显示全部楼层
有中文版的
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药徒
发表于 2014-8-21 20:29:10 | 显示全部楼层
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药徒
发表于 2014-8-22 10:12:49 | 显示全部楼层
左司马 发表于 2014-8-21 10:26
矣,学好英文,很有必要!!!

言之有理!

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好好学习,天天向上……  发表于 2014-8-22 10:31
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