偏差和CAPA管理仍然是检察官关注的重点

一沙一叶

偏差和CAPA现在依然是检查中的热点话题。检查人员对于他们检查发现做出的总结中显示事情并不总是尽如人意。

最近，UK官方MHRA发布了一份报告 MHRA GMP Inspection Deficiency Data Trend 2016,包含很吸引人并且广泛的信息，涵盖了324次在2016年进行的检查。根据这份报告，关于“质量体系”的缺陷是目前在检查中发现最多的。

就像之前那些年，对于偏差、调查和CAPA的适当的处理再次引发了很多担心。仔细查看那些检查发现项的例子，很明显，根本原因分析、影响评估和相关的措施仍然是多数公司的挑战：

偏差没有被充分的记录和调查

偏差的调查不够深入并且没有捕捉到所有相关的信息

调查过程中缺少细节

根本原因并不总是被充分考虑

并没有执行适当的CAPAs

偏差和执行的CAPAs并没有适当的评估质量影响

可能没有采取适当的措施来防止再发生

没有记录的措施来考虑预防

没有符合质量风险管理的原则的评估CAPA有效性的流程

FDA又如何呢？在最近发给UK的Porton Biopharma的一封警告信中，US FDA举例说明该公司没有“对任何无法解释的异常或者任何批次或者组件无法满足质量标准进行彻底的调查”，而且他们直接指出了CAPA的问题：

“当时进行的唯一的改正是更新标准操作规程”

“你们公司的CAPA计划是不充分的”

“我们鼓励你们考虑额外的CAPA来降低风险”

“你们公司没有执行及时充分的CAPA”

01月18日，FDA对印度的CTX Life Sciences发出了一封警告信，结论是公司无法保证“所有生产偏差被汇报并评估并且严重偏差被调查，结论被记录”。涉及到的批次产品在“在对严重偏差进行充分调查”之前就已经做出了处理决定。

Deviations and CAPA remain hot topics in inspections. The inspectorates' summaries of their observations show that things do not always work as desired. Recently, the U.K. authority MHRA (Medicines and Healthcare Products Regulatory Agency) published some very interesting and comprehensive information in their MHRA GMP Inspection Deficiency Data Trend 2016, covering 324 GMP inspections performed in 2016. According to the report, deficiencies relating to 'Quality Systems' are by far the most prevalent observed during inspections.

As in the previous years, appropriate handling of deviations, investigations and CAPA again causes a lot of concerns. Taking a closer look at the examples of the findings it becomes obvious that root cause analysis, impact assessment and associated actions are still challenging for many companies:

• Deviations were not fully recorded and investigated
• Deviation investigations did not include an appropriate level of investigation and did not capture all relevant information
• Significant lack of detail in investigations
• Root cause was not always adequately considered
• Appropriate CAPAs were not implemented
• The quality impact of the deviation and CAPAs implemented were not appropriately assessed
• Appropriate measures may not have been taken to prevent reoccurrence
• No recorded measures to consider prevention
• No process for assessing the effectiveness of CAPA in line with Quality Risk Management principles
  

And what about the FDA? In a recent Warning Letter to Porton Biopharma in the U.K. from January 19, 2017, the US Food and Drug Administration (FDA) cited the company for failing to "thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications" and they directly refer to corrective action and preventive actions:

• "The only correction implemented at that time was to update your standard operating procedure"
• "Your firm's corrective action and preventive action (CAPA) plan was inadequate"
• "We encourage you to consider additional CAPA to mitigate risk"
• "Your firm has failed to implement prompt and sufficient corrective and preventive actions"
  

On January 18th, the FDA sent a Warning Letter to the Indian API manufacturer CTX Life Sciences, with the conclusion that the company failed to "ensure all production deviations are reported and evaluated, and that critical deviations are investigated and conclusions are recorded" and that batch disposition was made before "adequate investigations into these significant deviations" were conducted.

syhorchid

谢谢分享

tangbx212

都存在同样的问题，得警觉

一片红云

谢谢分享！这个确实是这样

岁寒三友

这个不会变 肯定是检查重点

新华123

非常感谢分享，其实还是考验企业是否能以诚信，专业的质量素养对待自己的产品质量，有风险意识，以诚信对待患者。

zysx01234

质量保证部门的检查内容偏差台账、CAPA台账是必看内容，了解下这个企业一年有多少统计的数量，这些管理是否真正做到位还是就简单记录下应付检查

大厂这块做的相对规范完整，小厂就与化工厂无异可能管理人员搞不来吧还是脑子不行呢

一沙一叶

新华123 发表于 2017-5-12 07:48
非常感谢分享，其实还是考验企业是否能以诚信，专业的质量素养对待自己的产品质量，有风险意识，以诚信对待 ...

这个还不算诚信的问题吧

一沙一叶

zysx01234 发表于 2017-5-12 08:28
质量保证部门的检查内容偏差台账、CAPA台账是必看内容，了解下这个企业一年有多少统计的数量，这些管理是否 ...

CAPA可以看出水平啊

jianglinluye

都存在同样的问题，得警觉

一沙一叶

jianglinluye 发表于 2017-5-12 15:23
都存在同样的问题，得警觉

是啊，需要深入

xqliu

关注。。。

北重楼

一直都是检查重点

werewolfman

学习。

hualangzi

谢谢楼主分享