SOP Guide for Pharma

Sterile Injectable Manufacturing: SOP for Barcode Verification during Dispensing – V 2.0

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Sterile Injectable Manufacturing: SOP for Barcode Verification during Dispensing – V 2.0

Standard Operating Procedure for Barcode Verification during Dispensing


Department Sterile Injectable Manufacturing
SOP No. SOP/SIM/105/2025
Supersedes SOP/SIM/105/2022
Page No. Page 1 of 10
Issue Date 18/06/2025
Effective Date 20/06/2025
Review Date 18/06/2026

1. Purpose

To define the procedure for verifying barcode-labeled raw materials during dispensing operations in sterile injectable manufacturing, ensuring proper material identification, traceability, and reduction of human error.

2. Scope

This SOP applies to all materials that are dispensed in the dispensing area and are equipped with barcode labels, including

APIs, excipients, and packaging components used in sterile injectable manufacturing.

3. Responsibilities

  • Dispensing Operator: Responsible for scanning and verifying each barcode during dispensing.
  • Production Supervisor: Ensure barcode scanning system is functional and records are maintained.
  • QA Personnel: Verify the integrity of the barcode verification system and audit its use periodically.
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4. Accountability

The Production Manager is accountable for the implementation and compliance with this procedure.

5. Procedure

5.1 System Setup

  1. Ensure that barcode scanners are calibrated and operational before starting any dispensing activity.
  2. Verify the software connection to the central inventory database.
  3. Ensure each material has a barcode label generated through ERP or validated labeling software.

5.2 Barcode Verification

  1. Before dispensing, scan the barcode on the raw material container using the designated scanner.
  2. The system must automatically match the scanned code with the batch number, material name, and quantity.
  3. If mismatch or error is detected, stop the dispensing process and notify the supervisor.
  4. Upon successful verification, print a verification slip and attach it to the dispensing worksheet (Annexure-1).
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5.3 Backup Procedure

  1. In the event of scanner failure, initiate manual verification using approved documents and log the incident.
  2. QA must authorize the continuation of manual verification and document it in the barcode deviation log (Annexure-2).

5.4 Post-Dispensing

  1. Ensure verification slips and barcode logs are archived with batch manufacturing records.
  2. All unused labels must be defaced and disposed of as per SOP for Label Management.

6. Abbreviations

  • ERP: Enterprise Resource Planning
  • QA: Quality Assurance
  • SOP: Standard Operating Procedure

7. Documents

  1. Dispensing Barcode Verification Slip – Annexure-1
  2. Barcode Deviation Log – Annexure-2

8. References

  • GMP Guidelines – WHO, US FDA
  • ICH Q10 – Pharmaceutical Quality System
  • Company ERP System User Manual
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9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation Manufacturing Executive QA Executive Head QA
Department Production Quality Assurance Quality Assurance

11. Annexures

Annexure-1: Dispensing Barcode Verification Slip

Date Material Name Batch No. Quantity Scanned By Status
18/06/2025 Citric Acid CA202506 1.2 kg A. Kadam Verified

Annexure-2: Barcode Deviation Log

Date Material Error Observed Action Taken QA Sign
17/06/2025 Glucose Mismatch in batch number Manual verification authorized S. Desai

Revision History

Revision Date Revision No. Details Reason Approved By
12/01/2022 1.0 Initial release New SOP QA Head
18/06/2025 2.0 System integration and backup procedure added System Upgrade QA Head
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