ECA新闻：又一封关于“数据完整性”的FDA警告信

20150826 ECA新闻：又一封关于“数据完整性”的FDA警告信  
GMP News
26/08/2015
Another FDA Warning Letter with Focus on "Data Integrity"
又一封关于“数据完整性”的FDA警告信
A Warning Letter issued by the US Food & Drug Administration (FDA) to an Indian API manufacturer on 13 July 2015 shows again a clear focus on the missing integrity of data. Specifically, the following issues are addressed:
美国FDA在2015年7月13日向印度原料药生产商签发了一份警告信，其中显示出对数据完整性缺失的关注。在其中特别强调了以下几点：
1. Activities were not recorded at the time they were carried out and original data were deleted:
相关活动实施时未及时记录，原始数据被删除：
Entries in the manufacturing protocols were made only days after the relevant activities had been conducted. Further, batches were released before all results were available.
生产方案里的数据是在实施后数天才输入的。另外，生产批次在获得所有结果前即已放行。
In particular the use of "rough notes" was criticised as these original data were completely destroyed after transfer in the batch records.
特别批评了使用“手记”的行为，这些原始数据在转移到批记录上面后被全部销毁。
2. Due to unauthorised access to data systems, data could be modified or deleted:
数据系统可以未经授权即进入，因此数据可以被修改或删除。
Specifically HPLC, GC, and Karl Fischer Titrators were concerned. For instance, for the GC instrument multiple copies of raw data were found in the waste. And there was no password regulation for the data systems of HPLC and GC equipment, and there were no audit trail functions either.
特别是HPLC、GC和卡尔费休滴定仪。例如，在GC仪器上的作废记录中发现多个原始数据的备份。HPLC和GC仪器没有密码管理，也没有审计追踪功能。
3. There were no training protocols for the cGMP training of employees.
员工没有CGMP培训计划。
Altogether there were great concerns about the authenticity and reliability of the data produced in this company. Thus the FDA requested a comprehensive CAPA plan within 15 working days upon receipt of the Warning Letter.
综上所述，FDA对该公司所产生数据的权威性和可靠性表示关注。因此FDA要求在收到警告信后15个工作日内提交全面的CAPA计划。
For detailed information please see the full Mahendra Chemicals Warning Letter.
详细信息参见FDA官网发布的MAHENDRA CHEMICALS的警告信全文。
Source: FDA, United States
http://zhuyujiao1972.blog.163.com/blog/static/98694727201572682514168/

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