Follow
1. On completion of actions, the department head shall certify that the proposed CAPA is completed and implemented along with associated actions.
2. QA shall verify the implementation and completion of CAPA with the review of supporting documents and certify the same.
3. Any change proposed as a result of CAPA shall be through the SOP on Change Control Reference of the same shall be mentioned in the CAPA format.
4. All Change Controls, Deviations, Discrepancy, Incident Reports giving rise to CAPA shall be addressed through CAPA form.
5. All facility up-gradations / Capital purchase requirements / major changes in the quality system and compliance to regulatory commitments giving rise to CAPA shall be addressed through CAPA form.
6. The record of each CAPA shall be maintained.
7. Copy of the completed CAPA shall be provided to the concerned Dept. Head by QA Department Head shall compile the CAPA information and submit the summary to the Management during GMP Committee meeting / Management Review Meeting.
8. Management shall review/verify the same quarterly in Management Review Meeting.
9. Information and documents related to CAPA drawn from internal audits, external/ Customer audits and regulatory inspections are considered confidential and can only be made available to regulatory review when approved by Director technical and Vice President QA.
Source documents of CAPA are identified as:
• GMP Investigations
• Deviations
• Change control
• Laboratory (OOS) Investigations
• Internal Audit Reports
• External / Customer Audits
• Annual Product Reviews
• Regulatory Inspection Reports
• Management Action Plans
• Changes in regulatory / Pharmacopoeia requirements
• Product Failures
• Complaints
• Product recall
• Returned Goods
• Incidence Reports
• Discrepancies
