FDA给印度MAHENDRA CHEMICALS原料药生产商的警告信

julia朱玉姣

A Warning Letter issued by the US Food &Drug Administration (FDA) to an Indian API manufacturer on 13 July 2015 showsagain a clear focus on the missing integrity of data. Specifically, thefollowing 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 theywere 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 onlydays after the relevant activities had been conducted. Further, batches werereleased 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" wascriticised as these original data were completely destroyed after transfer inthe 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 couldbe 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 wereconcerned. For instance, for the GC instrument multiple copies of raw data werefound in the waste. And there was no password regulation for the data systemsof 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 trainingof employees.

员工没有CGMP培训计划。

Altogether there were great concerns about theauthenticity and reliability of the data produced in this company. Thus the FDArequested a comprehensive CAPA plan within 15 working days upon receipt of theWarning 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。

红茶.

印度这两年差不多是毁掉了。