Standard Operating Procedure for Label Reconciliation during Dispensing
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/108/2025 |
| Supersedes | SOP/SIM/108/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
To define the procedure for reconciliation of labels used during the dispensing of materials for sterile injectable manufacturing to prevent label mismatch, mix-ups, and ensure GMP compliance.
2. Scope
This SOP is applicable to all labeling activities carried out in the dispensing areas related
to sterile injectable materials, including APIs and excipients.
3. Responsibilities
- Dispensing Operator: Responsible for labeling all dispensed containers correctly and returning unused labels.
- QA Officer: Responsible for verification and reconciliation of labels post-dispensing.
- Production Supervisor: To ensure adherence to label reconciliation steps.
4. Accountability
The Head of Quality Assurance is accountable for implementation and compliance of this SOP.
5. Procedure
5.1 Label Generation
- Labels are generated from the approved batch record or ERP system.
- Each label shall include Material Name, Batch No., Quantity, Dispensed By, Date, and Status.
5.2 Label Application
- Labels shall be affixed to each dispensed container immediately after weighing.
- Partial quantities in different containers shall be labeled with ‘Part 1 of X’, ‘Part 2 of X’, etc.
5.3 Reconciliation Process
- At the end of the dispensing process, all unused labels must be returned to QA.
- QA must count:
- Total labels printed
- Total labels used
- Total labels returned
- Any discrepancy must be investigated and documented in the Label Reconciliation Form (Annexure-1).
5.4 Label Destruction
Unused and damaged labels shall be destroyed in the presence of QA personnel and recorded in the Destruction Logbook (Annexure-2).
5.5 Label Storage and Traceability
- Used labels shall remain on dispensed containers through manufacturing stages.
- Reconciliation records must be attached to the Batch Manufacturing Record.
6. Abbreviations
- QA: Quality Assurance
- ERP: Enterprise Resource Planning
- SOP: Standard Operating Procedure
7. Documents
- Label Reconciliation Form – Annexure-1
- Label Destruction Logbook – Annexure-2
8. References
- EU GMP Guidelines – Chapter 5 and Annex 1
- Company Quality Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Dispensing Executive | QA Executive | Head QA |
| Department | Production | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Label Reconciliation Form
| Batch No. | Material | Labels Printed | Used | Returned | Destroyed | Verified By |
|---|---|---|---|---|---|---|
| INJ-235 | Lactose | 6 | 4 | 2 | 2 | S. Mishra |
Annexure-2: Label Destruction Logbook
Record of destroyed labels including reason, method, date, and witness signature.
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 05/01/2022 | 1.0 | Initial issue | New SOP | QA Head |
| 18/06/2025 | 2.0 | Added destruction log requirement | Regulatory Compliance | QA Head |