How to know about CAPA || Corrective And Preventive Action || Pharma Guide ||

How to know about CAPA || Corrective And Preventive Action || Pharma Guide ||

Corrective action:
Action taken to rectify, fix or correct a specific deviation, defect or undesirable situation.

Preventive action:
Action taken to eliminate the cause of deviation, defect, or other undesirable situation in order to prevent the future occurrence of such or similar an event.

Source documents of CAPA are identified as:
GMP investigations
Deviations
Laboratory investigations
Internal audit reports
External audit reports
Customer audit reports
Regulatory inspection reports
Product failures
Complaints
Returned goods
Incidence reports

Source document shall provide the proposed corrective and preventive actions.

The proposed corrective and preventive actions shall be approved by QA prior to implementation.

The proposed corrective and preventive actions shall be verified during CAPA evaluation in form.

The CAPA form shall be treated as a tracking form of corrective and preventive actions from the source document.

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