CAPA Management | A Systematic Approach
CAPA system enables organizations to address deviations and prevent recurrence to maintain product quality and regulatory compliance.
Regulatory Requirements
- FDA: Requires manufacturers to establish and maintain CAPA procedures to identify and resolve product issues, ensuring continuous quality
- ICH Q10: Emphasizes the role of CAPA in ongoing quality improvements to maintain product integrity across its lifecycle
- EU GMP: Mandates CAPA processes for managing deviations and fostering continuous improvement
For Complaints and Recalls, requires a formal CAPA system for managing complaints and recalls to prevent recurrence
Key Steps of CAPA
Identification
- Source Identification: CAPA can be triggered by deviations, audit findings, customer complaints, adverse events, or internal reviews
- Initial Documentation: Record the issue in a CAPA log
Evaluation
- Impact Assessment: Evaluate how the issue impacts product quality, patient safety, and regulatory compliance
- Risk Assessment: Assess the severity and likelihood of recurrence to prioritize actions based on the potential impact
Investigation
- Use RCA tools to determine root causes, gathering necessary data to support a thorough investigation
Action Plan
- Immediate Action: A temporary, swift response to contain the problem, prevent further impact, and control risks while investigation is ongoing
- Corrective Actions: A permanent action to eliminate identified RC in order to prevent recurrence
- Preventive Actions: A proactive measures designed to prevent potential future issues by addressing systemic risks or weak points
- Action Plan: A detailed plan outlining specific actions, timelines, and personnel responsible for implementing each action
Implementation
- Implement the action plan, ensuring tasks adhere to established timelines and responsibilities
- Maintain thorough records of all actions taken to support traceability and future audits
Verification & Effectiveness Check
- Ensure all corrective and preventive actions have been implemented according to the plan
- Monitor outcomes to confirm the actions effectively resolved the issue and prevented recurrence
Closure
- Conduct a final review to confirm that all CAPA actions have been completed and verified for effectiveness
- Close the CAPA log and maintain all related documentation
Roles and Responsibilities
- CAPA Coordinator: Oversees CAPA process, including documentation and tracking progress
- QA: Reviews CAPA plan and ensures compliance with quality standards
- RCA Team: Conducts thorough investigations to identify root causes
- RA: Manages regulatory submissions (If needed)
Best Practices
- Maintain detailed records at every stage, ensuring traceability and transparency
- Involve team members from relevant departments to ensure a comprehensive approach to CAPA
- Regularly review CAPA processes to enhance effectiveness
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Resource Person: Alaaeldin Rashad
