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

1. Each material container will have a barcode label containing the following:
   • Material Code
   • Material Name
   • Batch Number
   • Vendor Code
   • Storage Location
   • QR/Barcode Image
2. Barcode must be generated using approved barcode software linked to ERP/WMS system.
3. Barcode labels should be printed on non-removable adhesive paper and resistant to water and temperature variations.

5.2 Barcode Labeling During Receiving

1. After physical verification and document check, generate a unique barcode for each container.
2. Affix the barcode label to the visible side of the container.
3. Scan the barcode into the warehouse system and assign to “Quarantine” status.
4. Record entry in the “Barcode Receiving Log” (Annexure-1).

5.3 Barcode Usage During Material Movement

1. For internal movement (e.g., from Quarantine to Released Area), scan the barcode to update location in system.
2. For sampling and dispensing, scan barcode at the time of activity and enter details in the “Activity Log.”
3. Every scan must trigger an audit trail within the warehouse software.

5.4 Barcode Use During Issuance

1. Warehouse executive selects material based on FEFO/FIFO and scans the barcode during issuance.
2. ERP will generate an “Issuance Confirmation Slip” automatically (Annexure-2).
3. Label the dispensed container with a duplicate barcode label (if split).

5.5 Barcode System Maintenance and Audit

1. Barcode printers and scanners must be checked for calibration or functionality monthly.
2. Logs of unscanned or failed barcode transactions must be reviewed weekly by QA.
3. 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

1. Barcode Receiving Log (Annexure-1)
2. Issuance Confirmation Slip (Annexure-2)
3. 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