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

1. Ensure barcode scanners (wired or wireless) are calibrated, functional, and connected to the barcode system.
2. Check printer and software configurations to confirm correct barcode format (EAN, QR, or DataMatrix) as per batch requirement.
3. Obtain the list of valid barcodes generated for the specific product batch from the labeling system.
4. Perform a trial scan on 5 units to verify readability and database validation.

5.2 Barcode Scanning Process

1. Place finished gel units on the scanning platform or conveyor with barcode facing upward.
2. Scan each unit individually using the handheld or inline scanner.
3. Ensure that the system captures each barcode and confirms validation against the batch code database.
4. For unscannable or damaged barcodes, segregate those units in the designated “Hold” area for rework or relabeling.
5. Document the barcode scanning status in the Barcode Scanning Logbook (Annexure-1).
6. Continue scanning until 100% of the batch has been verified.

5.3 Post-Scanning Activities

1. Generate a Barcode Scanning Summary Report (Annexure-2) at the end of the batch.
2. Send the report to the QA department for review and recordkeeping.
3. Return unscannable units (if relabeled) for re-scanning and verification.
4. 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

1. Barcode Scanning Logbook – Annexure-1
2. Barcode Scanning Summary Report – Annexure-2
3. Label Issuance Register
4. 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