Manager is accountable for ensuring that CAPA procedures are followed. The Production and QC teams are responsible for providing information regarding any deviations or non-conformances and implementing corrective actions. The regulatory team ensures all corrective and preventive actions meet the necessary regulatory standards.

5. Procedure

5.1 Identification of Non-Conformances

1. Identify non-conformances through routine audits, inspection reports, customer complaints, or quality control testing.
2. Document all non-conformances, including a description of the issue, affected batch or product, and initial observations (Annexure-1).
3. Assess the severity of the non-conformance to determine whether immediate corrective action is required to prevent further impact on product quality.

5.2 Investigation of Root Cause

1. Investigate the root cause of the non-conformance. This may involve reviewing batch records, conducting interviews, and analyzing production processes and equipment (Annexure-2).
2. Use tools like Root Cause Analysis (RCA), Fishbone Diagram, or Failure Mode Effect Analysis (FMEA) to identify underlying causes (Annexure-3).
3. Determine if the issue is isolated or if it could affect future batches or processes.

5.3 Corrective Action (CA) Implementation

1. Develop corrective actions to address the root cause of the non-conformance. Corrective actions may include process changes, equipment maintenance, training, or changes to standard operating procedures (SOPs) (Annexure-4).
2. Implement the corrective action immediately or within a defined timeframe. Document the implementation process and results (Annexure-5).
3. Verify that the corrective action has effectively resolved the non-conformance and prevent recurrence.

5.4 Preventive Action (PA) Implementation

1. Develop preventive actions to eliminate the risk of recurrence of the issue in the future. This may include modifying procedures, adding additional controls, or performing routine maintenance on equipment (Annexure-6).
2. Implement preventive actions as part of the continuous improvement process.
3. Verify the effectiveness of preventive actions by conducting periodic reviews and inspections to ensure no recurrence of the non-conformance.

5.5 Verification and Effectiveness Check

1. Once corrective and preventive actions are implemented, conduct effectiveness checks by reviewing batch records, inspecting affected processes, or conducting re-testing.
2. Ensure that corrective actions have resolved the issue and that preventive measures are actively reducing the risk of recurrence (Annexure-7).
3. If the corrective actions or preventive measures are ineffective, revisit the investigation and take further corrective actions.

5.6 Documentation and Record Keeping

1. Ensure that all CAPA records, including investigations, corrective actions, preventive actions, and effectiveness checks, are documented and securely stored (Annexure-8).
2. Retain CAPA records for a minimum of 5 years or as required by applicable regulations.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• CAPA: Corrective and Preventive Action
• RCA: Root Cause Analysis

7. Documents

1. Non-Conformance Report (Annexure-1)
2. Root Cause Analysis Report (Annexure-2)
3. Corrective Action Plan (Annexure-4)
4. Implementation Report (Annexure-5)
5. Preventive Action Plan (Annexure-6)
6. Effectiveness Check Results (Annexure-7)
7. CAPA Documentation Records (Annexure-8)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• GMP Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Non-Conformance Report

Non-Conformance ID	Description	Batch Number	Raised By	Corrective Action Required
NC001	Potency out of specification	Batch123	John Doe	Recalibrate equipment and retest

Annexure-2: Root Cause Analysis Report

Root Cause ID	Cause Description	Corrective Action
RCA001	Incorrect calibration of tablet hardness tester	Recalibrate and implement routine calibration checks

Annexure-3: Corrective Action Plan

Action ID	Action Description	Completion Date
CAP001	Recalibrate tablet hardness tester	06/03/2026

Annexure-4: Implementation Report

Action ID	Implemented By	Result
CAP001	Jane Smith	Successful recalibration

Annexure-5: Preventive Action Plan

Action ID	Action Description	Completion Date
PA001	Implement daily calibration checks for tablet hardness tester	07/03/2026

Annexure-6: Effectiveness Check Results

Action ID	Test Conducted	Result	Action Verified By
PA001	Tablet hardness testing	Passed	QA Manager

Annexure-7: CAPA Documentation Records

Document Type	Location	Retention Period
Corrective Action Plan	Document Archive	5 years

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial SOP creation	New process	QA Head
01/02/2025	2.0	Added more detailed documentation requirements	Annual review	QA Head