【审计追踪】FDA警告信：印度Cadila厂商Current FDA Warning Letter for Manuf...

清歌一曲月如霜

FDA警告信向印度制造商印度Cadila医疗保健有限公司（原料药和医药产品的两个生产基地）23十二月2015。信中着重对OOS结果和数据完整性的缺乏不恰当的评论。它具体涉及以下问题：
OOS：
OOS结果在实验室没有妥善检查。在与效力和内容一致性规范的生产中，所制造的的钠片剂有偏差。这些偏差已被观察到在过去的检查中，美国食品药品管理局。CAPA措施到目前为止是这样无效。
这些片剂的制造工艺还没有得到充分的控制。
公司要求列出所有批次的华法林钠片连同他们的缺货和趋势（OOT！）结果-不仅为美国市场，但所有市场的所有批次生产的所有市场！
在其响应于美国食品药品管理局，该公司还应该对如何优化工艺设计在制造组织中的命题，以提高在未来的内容的均匀性，检测，厚度或其他相关的关键质量属性。关于这一点，估计的过程能力也应该在。
此外，在外部不同药店Cadila投诉或批发商没有完全随访，无原因的分析已经完成。
数据/计算机系统的完整性：
关于计算机化系统，没有足够的控制到位之前，修改或删除数据。在QC实验室，检查组发现，实验室管理员不得不删除数据从卡尔菲舍尔该软件作为审计跟踪功能不活化的能力。此外，8名分析师分享一个单一的用户名和密码组合。因此，它不能被证明是谁经营这个仪器系统。
美国食品药品管理局还注意到一个含有水分含量结果的数据被删除。删除的数据并没有被考虑在所有的批处理发布的决定，即删除此数据既没有被确定，也没有审查。
最后，美国食品药品管理局批评了“非官方”实验室笔记本电脑的质量相关文件的几次。
所有的，在该公司所产生的数据的真实性和可靠性方面有主要的关注。FDA已要求全面CAPA计划15个工作日内收到的警告信。
了解更多细节请参见完整Cadila医疗保健有限公司的警告信。
来源：美国食品及药物管理局


Current FDA Warning Letter for Manufacturer Cadila in India

The FDA addressed a Warning Letter to the Indian Manufacturer Cadila Healthcare Limited in India (two production sites for APIs and medicinal products) on 23 December 2015. The letter focuses on the inappropriate review of OOS results and the lack of data integrity. It specifically addresses the following issues:
OOS:
OOS results in the laboratory haven't been properly examined. There have been deviations in the manufactured warfarin sodium tablets in association with potency and content uniformity specifications. Those deviations had already been observed in past inspections of the FDA. The CAPA measures taken so far were thus ineffective.
The manufacturing process for those tablets is not sufficiently controlled.
The company is asked to list all batches of the warfarin sodium tablets together with their OOS and Out-of-Trend (OOT!) results - not only those manufactured for the US-American market but all batches for all markets!
In its response to the FDA, the company should also make propositions on how to optimise process design in the manufacturing organisation in order to improve in the future content uniformity, assay, thickness or other relevant critical quality attributes. Concerning this, estimations with regard to the process capability should also flow in.
Furthermore - at Cadila - external complaints from diverse pharmacies or wholesalers haven't been completely followed up and no root cause analysis has ever been completed.
Integrity of data/ computerised system:
With regard to computerised systems, there are no sufficient controls in place before modifying or deleting data. In the QC laboratory, the inspection team found out that the laboratory manager had the ability to delete data from the Karl Fischer Tiamo software as the audit trail function wasn't activated. Moreover, 8 analysts had to share one single username and password combination. Consequently, it couldn't be demonstrated who had operated this instrument system.
The FDA also noticed that a data containing the moisture content results had been deleted. The deletion of the data hasn't been considered at all during the batch release decision - i.e. the deletion of this data has neither been identified nor reviewed.
Finally, the FDA criticised the records of "unofficial" lab notebooks for quality-related documents several times.
All in all, there are major concerns with regard to the authenticity and reliability of data generated in that company. The FDA has required a comprehensive CAPA plan within 15 workings days on receipt of the Warning Letter.
To find out more details please see the complete Cadila Healthcare Limited Warning Letter.
Source: FDA, USA

清歌一曲月如霜

数据/计算机系统的完整性：
关于计算机化系统，没有足够的控制到位之前，修改或删除数据。在QC实验室，检查组发现，实验室管理员不得不删除数据从卡尔菲舍尔该软件作为审计跟踪功能不活化的能力。此外，8名分析师分享一个单一的用户名和密码组合。因此，它不能被证明是谁经营这个仪器系统。
美国食品药品管理局还注意到一个含有水分含量结果的数据被删除。删除的数据并没有被考虑在所有的批处理发布的决定，即删除此数据既没有被确定，也没有审查。

清歌一曲月如霜

OOS结果在实验室没有妥善检查。

毒手药王邓智先

审计跟踪功能未开启

北重楼

实验室数据完整性是FDA的利器……剑锋所指，所向披靡

chenjiao501

我们有用cadila的原料

ravenhigh

翻译错误不少啊，lab notebooks就是实验记录本，不是笔记本电脑。OOS、OOT都翻译错了，软件翻译的？

charls

陆续出来会很多企业

syhorchid

FDA，药界世界警察。