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[GMP相关] CAPA Process Improvement

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药生
发表于 2021-1-23 08:14:05 | 显示全部楼层 |阅读模式

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本帖最后由 beiwei5du 于 2021-1-23 08:21 编辑

CAPA Process Improvement  
CAPA Status Quo.png

MDIC-CfQ-CAPA-Whitepaper-1.pdf

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药生
 楼主| 发表于 2021-1-23 09:24:53 | 显示全部楼层
CAPA Process Improvement Framework
CAPA Process Improvement.png
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药生
 楼主| 发表于 2021-1-23 09:14:40 | 显示全部楼层
Fast track CAPA Process:

Internal quality data sources are addressed using what we refer to as the Fast track
CAPA process. This process includes a risk assessment of the quality data source. Internal issues with
unacceptable risk, require action. Issues that identify what has already been established as acceptable risk
within the organizations risk analysis processes would be addressed at the discretion of the organization. This
process allows corrections and corrective actions to be embedded within the existing QMS processes (for
example, leveraging the nonconforming product process, the document change process, or validation
processes), rather than within a stand-alone CAPA. These actions will still meet the fundamental requirements
of CAPA but the documentation and activities may not formally be done under “a CAPA.” This provides process  
efficiencies by enabling the organization to solve problems quickly at the lowest level of the organization and
consolidates all information about a specific issue within a single system. The focus is on resolving the issue, not
deciding what system it is contained in. However, a word of caution: organizations will need to understand how
to get a consolidated view of all corrective action and preventive actions being taken. The Fast track CAPA
process entails levels of investigation, cause analysis documentation, decision points, and effectiveness checks
commensurate with the low risk. (See Figure 4 below). It should be noted that an organization that uses
multiple disconnected subsystems to process corrective and preventive actions will need to be deliberate about
generating a consolidated view of the improvement activities throughout the organization. See Best Practices
Section in Appendix 2 for an example of Fast track CAPA documentation.



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药生
发表于 2021-1-23 10:01:49 | 显示全部楼层
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药徒
发表于 2021-1-23 11:06:56 | 显示全部楼层
感谢分享!~
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药生
发表于 2021-1-24 19:18:06 | 显示全部楼层
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药徒
发表于 2021-12-10 10:15:55 | 显示全部楼层
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药徒
发表于 2021-12-10 13:45:05 | 显示全部楼层
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发表于 2021-12-10 18:14:19 | 显示全部楼层
谢谢分享,学习一下
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