Procedure for Barcoding and Serialization in Packaging

Department	Packaging/Quality Assurance (QA)/Production
SOP No.	SOP/Ointment/097
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for barcoding and serialization in the packaging of ointments. This ensures compliance with Good Manufacturing Practices (GMP), regulatory traceability, and product authenticity.

2. Scope

This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments responsible for generating, printing, verifying, and recording barcodes and serial numbers during packaging operations.

3. Responsibilities

• Packaging Operator: Prints and applies barcodes and serial numbers as per batch packaging record (BPR).
• Packaging Supervisor: Monitors barcode and serialization processes and ensures data accuracy.
• Quality Assurance (QA) Officer: Verifies barcode readability and serialization records.
• IT/Data Management Team: Maintains barcode and serialization database.
• QA Manager: Approves barcoded and serialized batches before distribution.

4. Accountability

The QA and Packaging Managers are accountable for ensuring barcoding and serialization processes meet GMP and regulatory requirements.

5. Procedure

5.1 Pre-Serialization and Barcode Setup

• Ensure that the barcode printing system is calibrated and functioning correctly.
• Verify the barcode format and serialization sequence according to regulatory requirements.
• Ensure that the correct batch number, expiry date, and manufacturing date are set in the system.

5.2 Barcode and Serial Number Printing

• Print barcodes and serial numbers on each unit, carton, and shipping case as per batch specifications.
• Ensure correct label alignment to prevent scanning issues.
• Use machine-readable codes (e.g., GS1 DataMatrix, QR codes) as per regulatory guidelines.

5.3 Verification of Barcodes and Serial Numbers

• Perform random sampling of printed barcodes to check legibility and accuracy.
• Use barcode scanners to verify that all barcodes are readable.
• Confirm that serialization follows a unique, non-repetitive sequence.

5.4 Data Recording and Traceability

• Record all generated serial numbers in the Serialization Log.
• Ensure batch-specific barcode data is stored in the serialization database.
• Verify that serialization data is linked to the batch packaging record (BPR).

5.5 Handling of Barcode and Serialization Errors

• Identify and segregate packaging units with unreadable or incorrect barcodes.
• Reprint or reapply barcodes for defective units.
• Document all errors and corrective actions taken.

5.6 Final QA Approval

• QA must perform a final inspection of barcode integrity and serialization compliance.
• Ensure that serialized data is reconciled before batch release.
• Approve the final packaged batch for shipment.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BPR – Batch Packaging Record
• GS1 – Global Standards for Serialization

7. Documents

• Serialization Log (Annexure-1)
• Barcode Verification Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q10 – Pharmaceutical Quality System
• GS1 Guidelines for Serialization

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Serialization Log

Date	Batch Number	Serialization Format	Starting Serial Number	Ending Serial Number	Verified By
01/02/2025	OINT-101	GS1 DataMatrix	1000001	1000500	QA Officer
01/02/2025	OINT-102	QR Code	2000001	2000500	QA Officer

Annexure-2: Barcode Verification Report

Date	Batch Number	Barcode Type	Scanned (Yes/No)	Defective Units	Corrective Action	Verified By
01/02/2025	OINT-101	GS1 DataMatrix	Yes	2	Reprinted	QA Officer
02/02/2025	OINT-102	QR Code	Yes	1	Reprinted	QA Officer

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head