Standard Operating Procedure (SOP) for Corrective Action and Preventive Action (CAPA)

Cleaning of High Performance Liquid Chromatography (HPLC)

1. Purpose:

To establish a systematic and effective process for identifying, implementing, and monitoring corrective and preventive actions (CAPA) within the organization, ensuring the continuous improvement of processes and products.

2. Scope:

This SOP for Corrective Action and Preventive Action (CAPA) applies to all departments and functions within the organization where CAPA processes are necessary to address non-conformances, deviations, and potential issues.

3. Definitions Involved in CAPA:

  • Corrective Action: An action taken to address and eliminate the root cause of an identified non-conformance, preventing its recurrence.
  • Preventive Action: Proactive measures taken to identify and mitigate potential issues before they occur, thereby preventing non-conformances.

4. Responsibilities:

4.1 Identification and Reporting:

  • Employees shall promptly report any non-conformances, deviations, or potential issues to their respective department heads or designated personnel.
  • Department heads or designated personnel shall assess the reported issue and determine whether it requires corrective or preventive action.

4.2 Root Cause Analysis:

  • The Quality Assurance (QA) department shall lead the investigation into the root cause of identified non-conformances.
  • Cross-functional teams may be formed to conduct a thorough analysis and identify underlying causes.

4.3 CAPA Plan Development:

  • Based on the root cause analysis, the QA department, in collaboration with relevant departments, shall develop a comprehensive CAPA plan.
  • The plan shall outline specific corrective or preventive actions, responsible individuals, timelines, and expected outcomes.

4.4 Implementation:

  • Responsible individuals shall execute the CAPA plan according to the established timeline.
  • Necessary resources and support shall be provided to ensure the successful implementation of actions.

4.5 Verification and Effectiveness:

  • The QA department shall verify the completion of CAPA actions and assess their effectiveness.
  • If the implemented actions are found to be effective, the CAPA process for the specific issue is considered closed.

4.6 Documentation and Records:

  • All CAPA activities, including investigations, plans, actions, and outcomes, shall be thoroughly documented and maintained.

5. Review and Continuous Improvement:

  • CAPA processes shall be periodically reviewed by the QA department to ensure their effectiveness and relevance.
  • Lessons learned from completed CAPA processes shall be utilized to enhance future preventive measures.

6. Communication:

  • Regular communication and updates on CAPA status shall be provided to relevant stakeholders, ensuring transparency and accountability.

7. Training and Awareness:

  • Employees shall receive training on the CAPA process, their roles, and the importance of timely reporting and action.

8. Non-compliance:

  • Failure to adhere to the CAPA process or provide accurate and timely information may result in appropriate corrective actions.

9. Approval:

  • This SOP for Corrective Action and Preventive Action (CAPA) has been reviewed and approved by [Name], [Title], on [Date].

10. Effective Date:

  • This SOP for Corrective Action and Preventive Action (CAPA) shall become effective on [Date].

11. References:

  • List any relevant policies, regulations, or guidelines that are referenced in this SOP for Corrective Action and Preventive Action (CAPA).

12. Attachments:

  • List any attachments or supporting documents related to this SOPcorrective and preventive actions (CAPA).
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