Standard Operating Procedure for Investigation and Corrective Action Preventive Action (CAPA) in Ointment Formulation
1) Purpose
The purpose of this SOP is to establish procedures for conducting investigations, implementing corrective actions, and preventive actions (CAPA) related to deviations, incidents, complaints, or non-conformances in ointment formulation processes or products.
2) Scope
This SOP applies to all personnel involved in investigating, documenting, and resolving deviations, incidents, complaints, or non-conformances in ointment formulation.
3) Responsibilities
– Quality Assurance (QA): Responsible for overseeing investigation and CAPA processes.
– Production Staff: Responsible for reporting deviations and assisting in investigations.
– CAPA Team: Responsible for implementing corrective and preventive actions.
4) Procedure
1. Deviation Reporting:
1.1 Identification:
1.1.1 Report deviations, incidents, complaints, or non-conformances promptly to QA.
1.1.2 Document initial observations and details of the deviation.
1.2 Classification:
1.2.1 Classify deviations based on severity and potential impact on product quality or safety.
1.2.2 Initiate immediate actions to mitigate risks associated with the deviation.
2. Investigation Process:
2.1 Root Cause Analysis (RCA):
2.1.2 Identify and verify the root cause(s) of the deviation or non-conformance.
2.2 Impact Assessment:
2.2.1 Assess the impact of the deviation on product quality, safety, or regulatory compliance.
2.2.2 Determine if any batch recall or customer notification is necessary based on the investigation findings.
3. Corrective Action (CA) Plan:
3.1 Development:
3.1.1 Develop a CA plan to address identified root causes and prevent recurrence.
3.1.2 Define corrective actions with specific tasks, responsibilities, and timelines.
3.2 Implementation:
3.2.1 Implement CA under controlled conditions, following approved procedures.
3.2.2 Monitor effectiveness of CA and verify implementation according to plan.
4. Preventive Action (PA) Plan:
4.1 Assessment:
4.1.1 Assess potential risks and vulnerabilities in ointment formulation processes.
4.1.2 Develop PA plan to prevent occurrence of similar deviations in the future.
4.2 Implementation:
4.2.1 Implement PA plan with proactive measures and process improvements.
4.2.2 Monitor PA effectiveness and adjust as necessary to enhance preventive measures.
5. Verification and Validation:
5.1 Verification of Effectiveness:
5.1.1 Verify effectiveness of implemented CA
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5.1.2 Document verification activities and results to confirm resolution of deviations.
5.2 Validation Requirements:
5.2.1 Perform validation activities if changes affect product quality, safety, or efficacy.
5.2.2 Ensure validation protocols are approved and followed according to regulatory requirements.
6. Documentation and Reporting:
6.1 CAPA Documentation:
6.1.1 Document all investigation findings, CAPA plans, and implementation details.
6.1.2 Include supporting evidence, such as data analyses and investigation reports.
6.2 Reporting Requirements:
6.2.1 Notify QA and relevant stakeholders of completed CAPA actions and outcomes.
6.2.2 Provide updates on CAPA progress during management review meetings.
7. Review and Closure:
7.1 Review Process:
7.1.1 Conduct CAPA effectiveness reviews to evaluate the impact of implemented actions.
7.1.2 Determine if additional actions or improvements are necessary based on review findings.
7.2 Closure and Documentation:
7.2.1 Close CAPA records after confirming effectiveness of corrective and preventive actions.
7.2.2 Archive CAPA documentation and maintain records for audit purposes.
8. Roles and Responsibilities:
8.1 Investigation Team:
8.1.1 Conduct thorough investigations using structured methodologies.
8.1.2 Ensure timely reporting and communication of investigation findings.
9. Abbreviations, if any
– QA: Quality Assurance
– SOP: Standard Operating Procedure
– CAPA: Corrective Action Preventive Action
– RCA: Root Cause Analysis
10. Documents, if any
– Deviation Reports
– Investigation Reports
– CAPA Plans and Records
11. Reference, if any
– FDA Current Good Manufacturing Practice (CGMP) Regulations
– ISO 13485:2016 Medical devices – Quality management systems
12. SOP Version
Version 1.0