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Corrective and Preventive Action (CAPA) Report

Corrective and preventive action (CAPA) noncompliance is one of the top reasons the FDA issues a noncompliance warning.  The purpose of a CAPA report in pharmaceutical industry is to document the actions taken to address the issue and prevent it from happening again in the future. This is a systemic approach to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.

The easiest way to respond to the FDA or any other Health Authority audit is with a letter that includes a CAPA report, so it’s simple and easy for the CAPA reviewer to follow the course of action. CAPA reports are typically initiated in response to customer complaints, internal audits, or other quality events.

Systematic and Organized Approach to Prepare a CAPA Report

STEP-1: Assign a CAPA number. This will be used to track the issue throughout the CAPA process.

STEP-2: The issue need to be described in detail. All relevant information, such as when and where the issue occurred, what product was involved, and who was affected – need to include

STEP-3: A root cause analysis need to be performed to identify the underlying causes of the issue. Once the root cause is identified, corrective and preventive actions can be developed to address the issue and prevent it from happening again.

STEP-4: All actions taken in the CAPA report need to be documented. This includes the date the issue was reported, the date the corrective and preventive actions were taken, and who was responsible for each action.

FDA requirements for a CAPA Report

  • All CAPA reports must be filed in a centralized database. This helps to ensure that all quality personnel are aware of the issue and can take appropriate action.
  • CAPA reports must also be reviewed and approved by a designated individual within the organization. This helps to ensure that the corrective and preventive actions are adequate and will actually address the issue.
  • All CAPA reports must be made available to the FDA/other HA upon request.

Regulatory bodies have no compulsions to use software solutions, but paper-based systems are more time consuming and manual system. They can end up more efforts with little output. That's why CAPA management software will be a nice option.

CAPA Report Format/Template

Always try to confirm that all of the failure modes from your selected sample of failure investigations have been captured within data summaries such as reports, pie charts, spreadsheets, Pareto charts, etc. Based on the failure mode analysis identify the CAPA and select the right person for taking responsibility.

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