Incident Report Format | Incident Report Template | Incident Report Format For Quality & GMP Incidents | Incident Report For Packaging Error (wrong label / misprinted batch number / missing leaflet) |
Incident Report No.: IR/PKG/2025/048
Incident Raised By: (Name, Sign & Date)
Department: Packaging
Date of Incident: 29-Aug-2025
Time: 04:30 PM
Category: ☑ Quality Impacting Incidents ☐ Quality Non-Impacting Incidents
(SECTION I) Description of the Incident:
During the secondary packaging of Batch No. TBL/2025/122, it was observed that carton labels contained incorrect batch number (TBL/2025/212 instead of TBL/2025/122). Additionally, in one case, cartons were found without product leaflet (Patient Information Leaflet). The error was identified by QA during in-process packaging inspection.
(SECTION II) Immediate Action:
- Packaging activity was immediately stopped.
- All packed cartons were quarantined and labeled as “On Hold – Pending QA Decision”.
- Suspect labels and cartons were segregated for reconciliation.
- Packaging line was cleared and documented.
Action Taken By: Packaging Officer (Name, Sign & Date)
Action Checked By: Packaging Head (Name, Sign & Date)
Preliminary Investigation (Root Cause for Incident):
- Wrong label: Misplacement of label rolls during line setup, not cross-verified.
- Missing leaflet: Operator oversight during manual leaflet loading in cartonator machine.
- Inadequate line clearance before batch start.
Department Head: (Sign, Date & Name)
(SECTION III) Classification of Errors / Events responsible for Incident:
☐ Breakdown of an Equipment / Instrument / Utility Machine
☐ Malfunctioning of an Equipment / Instrument / Utility Machine
☐ Power Failure
☐ Documentation Error
☑ Human Error
☐ Others
(SECTION IV) Suggested Corrective Action & Preventive Action To Be Taken:
Corrective Action:
- Stop packaging and perform 100% check of packed cartons for correct batch number and leaflet presence.
- Destroy incorrect labels as per SOP for reconciliation.
Preventive Action:
- Introduce dual verification (by Packaging + QA) for label roll and leaflet before line startup.
- Train packaging staff on importance of line clearance and reconciliation.
- Implement barcode scanning system for label verification.
- Automate leaflet insertion with sensor-based detection to prevent missing leaflets.
Responsible Staff: Packaging Supervisor (Name, Designation)
Target Date for Completion: 12-Sep-2025
Suggested By: Department Head (Sign, Date & Name)
Reviewed By: Plant Head (Sign, Date & Name)
(SECTION V) Evaluation and Recommendation by QA / VP Technical:
- Perform 100% physical check of all cartons from this batch.
- If discrepancies are corrected and results comply, batch may be released.
- QA to verify destruction records of incorrect labels.
Q.A. Head / VP Technical: (Sign, Date & Name)
(SECTION VI) Compliance of the Recommendations and Closure:
Verification Done By:
- Department Head (Sign, Date & Name)
- QA Head / VP Technical (Sign, Date & Name)
Final Conclusion with Estimated Commercial Loss:
Estimated loss of ~500 misprinted cartons & labels; batch release delayed by ~1 day.
Remarks: Incident Closed.
Head of Quality Assurance Department / VP Technical: (Sign, Date & Name)