Standard Operating Procedure for Barcode Verification during Dispensing
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/105/2025 |
| Supersedes | SOP/SIM/105/2022 |
| 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 verifying barcode-labeled raw materials during dispensing operations in sterile injectable manufacturing, ensuring proper material identification, traceability, and reduction of human error.
2. Scope
This SOP applies to all materials that are dispensed in the dispensing area and are equipped with barcode labels, including
APIs, excipients, and packaging components used in sterile injectable manufacturing.
3. Responsibilities
- Dispensing Operator: Responsible for scanning and verifying each barcode during dispensing.
- Production Supervisor: Ensure barcode scanning system is functional and records are maintained.
- QA Personnel: Verify the integrity of the barcode verification system and audit its use periodically.
4. Accountability
The Production Manager is accountable for the implementation and compliance with this procedure.
5. Procedure
5.1 System Setup
- Ensure that barcode scanners are calibrated and operational before starting any dispensing activity.
- Verify the software connection to the central inventory database.
- Ensure each material has a barcode label generated through ERP or validated labeling software.
5.2 Barcode Verification
- Before dispensing, scan the barcode on the raw material container using the designated scanner.
- The system must automatically match the scanned code with the batch number, material name, and quantity.
- If mismatch or error is detected, stop the dispensing process and notify the supervisor.
- Upon successful verification, print a verification slip and attach it to the dispensing worksheet (Annexure-1).
5.3 Backup Procedure
- In the event of scanner failure, initiate manual verification using approved documents and log the incident.
- QA must authorize the continuation of manual verification and document it in the barcode deviation log (Annexure-2).
5.4 Post-Dispensing
- Ensure verification slips and barcode logs are archived with batch manufacturing records.
- All unused labels must be defaced and disposed of as per SOP for Label Management.
6. Abbreviations
- ERP: Enterprise Resource Planning
- QA: Quality Assurance
- SOP: Standard Operating Procedure
7. Documents
- Dispensing Barcode Verification Slip – Annexure-1
- Barcode Deviation Log – Annexure-2
8. References
- GMP Guidelines – WHO, US FDA
- ICH Q10 – Pharmaceutical Quality System
- Company ERP System User Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Manufacturing Executive | QA Executive | Head QA |
| Department | Production | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Dispensing Barcode Verification Slip
| Date | Material Name | Batch No. | Quantity | Scanned By | Status |
|---|---|---|---|---|---|
| 18/06/2025 | Citric Acid | CA202506 | 1.2 kg | A. Kadam | Verified |
Annexure-2: Barcode Deviation Log
| Date | Material | Error Observed | Action Taken | QA Sign |
|---|---|---|---|---|
| 17/06/2025 | Glucose | Mismatch in batch number | Manual verification authorized | S. Desai |
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 12/01/2022 | 1.0 | Initial release | New SOP | QA Head |
| 18/06/2025 | 2.0 | System integration and backup procedure added | System Upgrade | QA Head |