Tablets: SOP for Corrective and Preventive Action (CAPA) Implementation – V 2.0
Standard Operating Procedure for Corrective and Preventive Action (CAPA) Implementation
| Department |
Tablet |
| SOP No. |
SOP/TAB/217/2025 |
| Supersedes |
SOP/TAB/217/2022 |
| Page No. |
Page 1 of 5 |
| Issue Date |
01/03/2026 |
| Effective Date |
06/03/2026 |
| Review Date |
01/03/2027 |
1. Purpose
The purpose of this SOP is to outline the procedure for identifying, investigating, and implementing Corrective and Preventive Actions (CAPA) to address deviations, non-conformances, or any issues within the tablet manufacturing process. The goal is to prevent recurrence and improve the overall quality management system.
2. Scope
This SOP applies to all tablet manufacturing processes where deviations, non-conformances, or potential quality issues arise. It includes the identification, investigation, analysis, and resolution of the problem through corrective and preventive actions.
3. Responsibilities
- Quality Assurance (QA) Manager: Responsible for overseeing the CAPA process, ensuring proper implementation, and verifying the effectiveness of corrective actions and preventive measures.
- Production Manager: Responsible for providing information on production deviations and assisting in the implementation of corrective actions.
- Quality Control (QC) Team: Responsible for investigating non-conformances related to testing and providing feedback for CAPA implementation.
- Regulatory Affairs Team: Ensures that corrective actions comply with regulatory requirements and are implemented accordingly.
4. Accountability
The QA 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
- Identify non-conformances through routine audits, inspection reports, customer complaints, or quality control testing.
- Document all non-conformances, including a description of the issue, affected batch or product, and initial observations (Annexure-1).
- 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
- Investigate the root cause of the non-conformance. This may involve reviewing batch records, conducting interviews, and analyzing production processes and equipment (Annexure-2).
- Use tools like Root Cause Analysis (RCA), Fishbone Diagram, or Failure Mode Effect Analysis (FMEA) to identify underlying causes (Annexure-3).
- Determine if the issue is isolated or if it could affect future batches or processes.
5.3 Corrective Action (CA) Implementation
- 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).
- Implement the corrective action immediately or within a defined timeframe. Document the implementation process and results (Annexure-5).
- Verify that the corrective action has effectively resolved the non-conformance and prevent recurrence.
5.4 Preventive Action (PA) Implementation
- 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).
- Implement preventive actions as part of the continuous improvement process.
- 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
- Once corrective and preventive actions are implemented, conduct effectiveness checks by reviewing batch records, inspecting affected processes, or conducting re-testing.
- Ensure that corrective actions have resolved the issue and that preventive measures are actively reducing the risk of recurrence (Annexure-7).
- If the corrective actions or preventive measures are ineffective, revisit the investigation and take further corrective actions.
5.6 Documentation and Record Keeping
- Ensure that all CAPA records, including investigations, corrective actions, preventive actions, and effectiveness checks, are documented and securely stored (Annexure-8).
- 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
- Non-Conformance Report (Annexure-1)
- Root Cause Analysis Report (Annexure-2)
- Corrective Action Plan (Annexure-4)
- Implementation Report (Annexure-5)
- Preventive Action Plan (Annexure-6)
- Effectiveness Check Results (Annexure-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
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Checked By |
Approved By |
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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 |