Warning: Your “Check CAPA” Light is On | Ask Cato:
The FDA has reported that over 50% of the top 10 Form FDA 483 observations and warning letters are related to one process: CAPA, otherwise known as Corrective and Preventive Actions.
"The requirements are summarized as follows:
- Analyze processes to identify the root cause of the nonconformance and to proactively identify potential causes of future nonconformance;
- Investigate the cause;
- Identify actions needed to correct and prevent nonconformance recurrence;
- Validate that the CAPA is effective and does not cause unintended adverse effects;
- Implement and record changes in procedures to correct and prevent the recurrence of noncompliance;
- Ensure direct dissemination of CAPA information to those responsible for assuring product quality to ensure adequate training for preventive actions; and
- Submit the relevant documentation on CAPA for management review."
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