EU Inspection Complaints due to inadequate Handling of OOS Results由于未充分处理OOS结果引发的EU检查违规
On August 08, 2017, a Statement of Non-Compliance with GMP was published on the Eudra GMDP website for Dr. Reddy's Laboratories Ltd. in India.
2017年8月8日，EU的GMDP数据库发布了印度Dr. Reddy's Laboratories的GMP不符合声明。
The findings from several GMP inspections of the manufacturer showed that the company does not operate in compliance with European GMP requirements. The following deficiencies were viewed as critical:
几个GMP检查人员在生产商处发现的缺陷显示该公司并未按欧盟GMP要求运行。以下缺陷被作为是关键缺陷：
In hundreds of cases, OOS results were systematically invalidated without traceable or scientifically based root-cause-analysis; the only reason given was "staff-errors".
在几百个案例中，OOS结果被系统性地宣布无效，而并没有可追踪的基于科学的根本原因分析，仅有的原因就是“员工失误”。
Deviation and OOS management including protocols-, review- and reporting-systems were designed and executed in such a way that all deviations, incidents and unusual events were systematically not documented.
偏差和OOS管理包括方案、审核和报告系统，其设计和实施情况使得所有偏差、事故和异常事件系统性地未进行记录。
Furthermore, the cleaning of rooms and direct-product-contact equipment had verifiably not been performed.
还有，房间清洁和直接与产品接触的设备清洁未经确认。
The consequences include:
后果包括：
Recall of already released batches
召回已经放行的批次
No deliveries to the EU until a successful re-inspection has been performed
在重新检查通过之前不能向EU发货
Withdrawal of the currently valid GMP certificate
撤销当前有效的GMP证书
Please also see the complete Eudra GMDP "Statement of Non-Compliance with GMP" for Dr. Reddy's Laboratories Ltd. in India.
详情参见欧盟的GMDP数据库。阅读(14)| 评论(0)
On August 08, 2017, a Statement of Non-Compliance with GMP was published on the Eudra GMDP website for Dr. Reddy's Laboratories Ltd. in India.
2017年8月8日，EU的GMDP数据库发布了印度Dr. Reddy's Laboratories的GMP不符合声明。
The findings from several GMP inspections of the manufacturer showed that the company does not operate in compliance with European GMP requirements. The following deficiencies were viewed as critical:
几个GMP检查人员在生产商处发现的缺陷显示该公司并未按欧盟GMP要求运行。以下缺陷被作为是关键缺陷：
In hundreds of cases, OOS results were systematically invalidated without traceable or scientifically based root-cause-analysis; the only reason given was "staff-errors".
在几百个案例中，OOS结果被系统性地宣布无效，而并没有可追踪的基于科学的根本原因分析，仅有的原因就是“员工失误”。
Deviation and OOS management including protocols-, review- and reporting-systems were designed and executed in such a way that all deviations, incidents and unusual events were systematically not documented.
偏差和OOS管理包括方案、审核和报告系统，其设计和实施情况使得所有偏差、事故和异常事件系统性地未进行记录。
Furthermore, the cleaning of rooms and direct-product-contact equipment had verifiably not been performed.
还有，房间清洁和直接与产品接触的设备清洁未经确认。
The consequences include:
后果包括：
Recall of already released batches
召回已经放行的批次
No deliveries to the EU until a successful re-inspection has been performed
在重新检查通过之前不能向EU发货
Withdrawal of the currently valid GMP certificate
撤销当前有效的GMP证书
Please also see the complete Eudra GMDP "Statement of Non-Compliance with GMP" for Dr. Reddy's Laboratories Ltd. in India.
详情参见欧盟的GMDP数据库。阅读(14)| 评论(0)
