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 |