Standard Operating Procedure for Use of Barcode System in Material Management in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/008/2025 |
| Supersedes | SOP/API/008/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a standardized procedure for the implementation and use of a barcode system for the labeling, tracking, and inventory control of raw materials in the API manufacturing warehouse. This enhances traceability, reduces manual errors, and improves GMP compliance.
2. Scope
This SOP applies to all personnel involved in material receiving, storage, movement, issuance, and inventory management using barcode scanning and printing technology in the warehouse.
3. Responsibilities
- Warehouse Executive: Generate, apply, and scan barcodes during material transactions.
- IT Officer: Maintain barcode software, scanners, printers, and troubleshoot issues.
- QA Officer: Review barcode usage logs and ensure data integrity compliance.
4. Accountability
The Warehouse Manager is accountable for the effective implementation, training, and compliance with barcode system procedures in material management activities.
5. Procedure
5.1 Barcode Format and Generation
- Each material container will have a barcode label containing the following:
- Material Code
- Material Name
- Batch Number
- Vendor Code
- Storage Location
- QR/Barcode Image
- Barcode must be generated using approved barcode software linked to ERP/WMS system.
- Barcode labels should be printed on non-removable adhesive paper and resistant to water and temperature variations.
5.2 Barcode Labeling During Receiving
- After physical verification and document check, generate a unique barcode for each container.
- Affix the barcode label to the visible side of the container.
- Scan the barcode into the warehouse system and assign to “Quarantine” status.
- Record entry in the “Barcode Receiving Log” (Annexure-1).
5.3 Barcode Usage During Material Movement
- For internal movement (e.g., from Quarantine to Released Area), scan the barcode to update location in system.
- For sampling and dispensing, scan barcode at the time of activity and enter details in the “Activity Log.”
- Every scan must trigger an audit trail within the warehouse software.
5.4 Barcode Use During Issuance
- Warehouse executive selects material based on FEFO/FIFO and scans the barcode during issuance.
- ERP will generate an “Issuance Confirmation Slip” automatically (Annexure-2).
- Label the dispensed container with a duplicate barcode label (if split).
5.5 Barcode System Maintenance and Audit
- Barcode printers and scanners must be checked for calibration or functionality monthly.
- Logs of unscanned or failed barcode transactions must be reviewed weekly by QA.
- Discrepancies or duplicates must be investigated as per deviation handling SOP.
6. Abbreviations
- ERP: Enterprise Resource Planning
- WMS: Warehouse Management System
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- FEFO: First Expiry, First Out
7. Documents
- Barcode Receiving Log (Annexure-1)
- Issuance Confirmation Slip (Annexure-2)
- Barcode Transaction Audit Log (Annexure-3)
8. References
- ICH Q7 – GMP Guidelines for Active Pharmaceutical Ingredients
- 21 CFR Part 11 – Electronic Records; Electronic Signatures
- WHO TRS 961 Annex 9 – Warehouse Management Practices
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | Rajesh Kumar | Sunita Reddy | Manoj Verma |
| Designation | Warehouse Executive | QA Executive | QA Manager |
| Department | API Manufacturing | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Barcode Receiving Log
| Date | Material | Batch | Container No. | Barcode ID | Scanned By |
|---|---|---|---|---|---|
| 13/04/2025 | Sodium Hydroxide | SH202504 | 01 | BARC00123 | Rajesh Kumar |
Annexure-2: Issuance Confirmation Slip
| Date | Material | Batch | Issued Qty | Barcode | Issued By |
|---|---|---|---|---|---|
| 13/04/2025 | Sodium Hydroxide | SH202504 | 50 kg | BARC00123 | Rajesh Kumar |
Annexure-3: Barcode Transaction Audit Log
| Date | Action | Barcode | User | Status | Remarks |
|---|---|---|---|---|---|
| 13/04/2025 | Scan at Dispensing | BARC00123 | RKumar | Success | — |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP | Barcode System Rollout | QA Head |
| 13/04/2025 | 2.0 | Included Audit Trail and ERP Sync | GMP Upgrade | QA Head |