Standard Operating Procedure for Barcode Scanning of Packaged Gel Products
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/094/2025 |
| Supersedes | SOP/GM/094/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 02/06/2025 |
| Effective Date | 04/06/2025 |
| Review Date | 02/06/2026 |
1. Purpose
This SOP outlines the standardized procedure for barcode scanning of packaged gel products to ensure correct identification, traceability, and inventory management before release and shipment.
2. Scope
This procedure applies to all final packaged gel units (tubes, jars, bottles) that require barcode scanning for
verification and entry into the warehouse management system at the pharmaceutical manufacturing unit.
3. Responsibilities
- Packaging Operator: Operate barcode scanners, ensure successful scans, and segregate error units.
- Line Supervisor: Verify barcode software configuration and system accuracy.
- IT Personnel: Maintain scanning system connectivity and perform troubleshooting.
- Quality Assurance: Conduct in-process and random barcode verifications.
4. Accountability
The Head – Manufacturing is accountable for barcode data integrity and process compliance for all packaged gel units.
5. Procedure
5.1 Pre-Scanning Preparation
- Ensure barcode scanners (wired or wireless) are calibrated, functional, and connected to the barcode system.
- Check printer and software configurations to confirm correct barcode format (EAN, QR, or DataMatrix) as per batch requirement.
- Obtain the list of valid barcodes generated for the specific product batch from the labeling system.
- Perform a trial scan on 5 units to verify readability and database validation.
5.2 Barcode Scanning Process
- Place finished gel units on the scanning platform or conveyor with barcode facing upward.
- Scan each unit individually using the handheld or inline scanner.
- Ensure that the system captures each barcode and confirms validation against the batch code database.
- For unscannable or damaged barcodes, segregate those units in the designated “Hold” area for rework or relabeling.
- Document the barcode scanning status in the Barcode Scanning Logbook (Annexure-1).
- Continue scanning until 100% of the batch has been verified.
5.3 Post-Scanning Activities
- Generate a Barcode Scanning Summary Report (Annexure-2) at the end of the batch.
- Send the report to the QA department for review and recordkeeping.
- Return unscannable units (if relabeled) for re-scanning and verification.
- Backup barcode scan data on secure servers or cloud storage as per data retention policies.
6. Abbreviations
- QA: Quality Assurance
- EAN: European Article Number
- QR: Quick Response
- SOP: Standard Operating Procedure
7. Documents
- Barcode Scanning Logbook – Annexure-1
- Barcode Scanning Summary Report – Annexure-2
- Label Issuance Register
- Packing Batch Record
8. References
- WHO GMP Guidelines on Labeling and Packaging
- Schedule M – Packaging and Labeling
- GS1 Standards for Barcode Implementation
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Barcode Scanning Logbook
| Sr. No. | Product Name | Batch No. | Unit Scanned | Result (OK/Rejected) | Remarks |
|---|---|---|---|---|---|
| 1 | |||||
| 2 | |||||
| 3 |
Annexure-2: Barcode Scanning Summary Report
| Product Name | Batch No. | Total Units | Scanned Successfully | Rejected Units | Date | Checked By |
|---|---|---|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 02/06/2022 | 1.0 | Initial version | New SOP creation | QA Head |
| 02/06/2025 | 2.0 | Added scanning summary report and data retention steps | Annual Review | QA Head |