FDA警告信 [上海迪赛诺化学制药有限公司] 2016年6月16日

kslam

FDA于2016年6月21日对上海迪赛诺化学制药有限公司(上海市张江高科技园区张衡路1479号)发警告信。

1. Failure to have laboratory control records that include complete data derived from all tests conducted to ensure compliance with established specifications and standards. 未具有化验室记录包括所有测试中的完整数据以确保符合既定质量标准。

2. Failure to ensure all production deviations are reported and evaluated, and that critical deviations are investigated and the conclusions are recorded. 未能确保所有的生产偏差都已报告和评价，对关键的偏差进行调查并记录结论。




补充内容 (2016-6-30 11:20):
2009年4月24日 - VAI
2012年6月7日 - NAI

一沙一叶

就这两点啊  

syhorchid

上海迪赛诺很牛皮啊

chenxian

谢谢分享！

kc1711422001

Thanks for sharing

fangyuan5

更关心这2点怎么整改！！！

北重楼

数据可靠性和企业大小没关系，关键还是平时是否重视的

kslam

我们的检查员在检查期间观察到的具体偏离包括但不限于以下内容：

1.    Failure to have laboratory control records that include complete data derived from all tests conducted to ensure compliance with established specifications and standards.
1.实验室控制记录包括执行的所有测试衍生出来的完整的数据不能确保符合已建立的质量指标和标准。

Your laboratory personnel conducted “unofficial” testing without appropriate documentation, justification, and investigation.
你们实验室人员执行了“非正式”测试没有适当地做记录、证明和调查。


The original, unofficial analyses were stored in a separate “Test” folder and were not part of the official quality control records. Our inspection found that your firm performed circa 8,400 of these unofficial chromatographic analyses between 2012 and 2014. According to your SOP-B-QC-022-01, Instrument Use Standard Operating Procedure, analysis of samples must be documented. The volume of data in these auxiliary “Test Folders” suggests that performing unofficial analyses is a common practice at your facility.
原始的、非正式的分析储存在一个单独的“测试”文件夹中，此记录并不是正式的质量控制记录的一部分。我们检查发现贵公司在2012和2014年执行了大约8400次这样的非正式的色谱分析。按照SOP-B-QC-022-01《仪器使用SOP》的规定样品的分析必须记录。在这些辅助的“测试文件夹”中的大量数据显示执行非正式的分析在贵工厂是一种常见的行为。


Your quality unit must review all pertinent analytical data when making batch release decisions in order to determine batch quality. During the inspection, a member of your staff told our investigator that you were now in the process of reviewing these unofficial analyses.
为了确定批产品质量做批记录放行决定时你们的质量部门必须审核所有相关的分析数据。在检查中，你们的一位员工告诉我们的检查员说你们现在正在审核这些非正式分析。


In your post-inspection response, you indicated that some of the analyses were related to out-of-specification (OOS) investigations, and you would review all of the approximately 8,400 injections by December, 2015. You also committed to continue reviewing all analytical data generated by your laboratory and to retrain employees.
在你们后来的检查反馈中，你们指出一些分析涉及到OOS调查，你们将在2015年12月前审核所有大约8400份分析。你们也承诺继续审核所有实验室产生的分析数据并重新培训员工。


Your response is inadequate because it lacks a comprehensive assessment of your laboratory practices and management oversight. Your response did not provide the extent of the unofficial analyses throughout your laboratory and the products affected.
你们的反馈是不充分的，因为缺乏你们实验室行为和管理监督的综合评估。你们的反馈没有提供在你们实验室非正式分析和影响产品的范围。


2.    Failure to ensure all production deviations are reported and evaluated, and that critical deviations are investigated and the conclusions are recorded.
2.未能确保所有生产偏差都被报告和评估、关键偏差都被调查和结论都被记录


Your firm failed to investigate and document a number of production deviations. During the inspection, our investigator found many electronic logs of production deviations in a folder titled “GMP Anomalies.” Our investigator randomly selected folder 01/2014 from your electronic log, compared it to your firm’s official deviation logbook for 2014, and found that the deviations in the “GMP Anomalies” folder were not investigated or reported in the official deviation logbook.
贵公司没有调查和记录一些生产偏差。在检查过程中，我们的检查员发现在一个文件夹“GMP异常”中有许多生产偏差的电子登记。我们的检查员从电子登记中随机选择了文件夹01/2014，比较了贵公司2014年正式的偏差登记本，发现在文件夹"GMP异常”中的偏差没有在正式的偏差登记本中调查和报告。


Production deviations included, but were not limited to:
生产偏差包括但不限于：

• out-of-limit temperature readings for critical process parameters
• 关键工艺参数的超过限度的温度读数
• incomplete batch records
• 不完整的批记录
• batch records pre-filled before manufacturing
• 批记录在生产前已填写
• failure to record temperature, humidity, and pressure
• 没有记录温度、湿度和压力
• failure to add portions of raw materials during manufacturing
• 在生产过程中没有添加部分原料
  

In your response, you attribute the root cause of these failures to deficient procedures and operators’ errors. You stated that you will conduct a retrospective review for all deviations made in the (b)(4) products “Production Coordination Log” from January 2014 through April 2015, to determine whether any CGMP deviations may have compromised product quality.
在你们的反馈中，你们把这些失效根本原因归结于程序缺陷和操作人员失误。你们声称你们将对从2014年1月到2015年4月产品“生产辅助记录”上记录的所有偏差进行回顾性审核来确定是否有任何cGMP偏差可能已经牵涉产品质量。


Your response is inadequate as your protocol did not include a thorough review of complaints to determine if undocumented deviations could be linked to product quality defects.
你们的反馈是不充分的，因为你们的方案没有包括对投诉的全面审核来确定没有记录的偏差是否与产品质量缺陷有关系。

Darkman

老外对整改的要求真的蛮高，不像国内

sd8073086

这个地址是不对的，张衡路1479是制剂工厂，名字是迪赛诺生物医药，这个是滨海的原料药工厂，迪赛诺化学制药。

genthsx

楼上对迪赛诺很熟悉啊

萧向天

唉，原来说的是问题不大呀，怎么还是出事了呢，轻视杀手了

sd8073086

genthsx 发表于 2016-6-30 08:55
楼上对迪赛诺很熟悉啊

是的，所以要出来声明一下。。。

scslk0045

关注数据完整性问题

jieudhl

这一招，好像从前也玩过，现在不敢了，要玩也玩台机啊

beiwei5du

sd8073086 发表于 2016-6-30 08:43
这个地址是不对的，张衡路1479是制剂工厂，名字是迪赛诺生物医药，这个是滨海的原料药工厂，迪赛诺化学制药 ...

办公室的地址是张衡路1479，不是工厂地址呢。

beiwei5du

WHO 第四次对迪赛诺的检查报告，FYI

qingqing青柠檬

路过，看看

liangliangliu12

数据完整性问题

beiwei5du

WHO 第三次对迪赛诺的检查报告，供大家学习。

The Quality Assurance department was particularly strong, which resulted in a high level of control but shall not exonerate other departments from assuming their responsibilities in ensuring compliance.