Elixir Department: SOP for Use of Barcode Systems During Dispensing – V 2.0

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Elixir Department: SOP for Use of Barcode Systems During Dispensing – V 2.0

Standard Operating Procedure for Using Barcode Systems During Material Dispensing

Department Elixir Department
SOP No. SOP/ELX/032/2025
Supersedes SOP/ELX/032/2022
Page No. Page 1 of 9
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

This SOP defines the procedure for the use of barcode scanning systems during the dispensing of raw materials and excipients in the Elixir Department to ensure accuracy, traceability, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel responsible for dispensing raw materials and excipients using barcode scanners for material identification, verification, and tracking during dispensing in the Elixir Department.

3. Responsibilities

  • Dispensing Operator:
    • Scan materials using the barcode reader and ensure correct entry into the system.
    • Label all dispensed materials with updated barcoded labels.
  • IT/Automation Officer:
    • Ensure the barcode system is functional and backed up regularly.
  • Production Supervisor:
    • Verify system logs and ensure proper barcode use during dispensing.
  • QA Personnel:
    • Review barcode records and verify accuracy of dispensing entries.
See also  Elixir Department: SOP for Line Clearance in Dispensing Area - V 2.0

4. Accountability

The Production Head of the Elixir Department is accountable for ensuring the use of barcode systems during

dispensing operations as per this SOP, and for maintaining electronic records in compliance with GMP.

5. Procedure

5.1 System Access and Verification

  1. Log in to the Material Dispensing System using authorized credentials.
  2. Verify the barcode scanner is calibrated and functional before each session.
  3. Check that the printer for barcode labels is operational and loaded with proper media.

5.2 Barcode Scanning for Material Identification

  1. Scan the barcode on the raw material/excipient container to retrieve:
    • Material Name
    • Batch Number
    • Storage Conditions
    • Approval Status
  2. Confirm that the scanned information matches the Batch Manufacturing Record (BMR).
  3. Reject the material if there is a mismatch or if the approval status is ‘Quarantine’ or ‘Rejected’.

5.3 Barcode Verification During Dispensing

  1. Once the correct material is confirmed, place the container inside the dispensing area or LAF.
  2. Dispense the required quantity using calibrated equipment and record the actual dispensed amount in the system.
  3. Generate a new barcode label indicating:
    • Material Name
    • Quantity Dispensed
    • Dispensed By
    • Date of Dispensing
    • Batch Number
  4. Affix the printed barcode label to the dispensed container.
See also  Elixir Department: SOP for Material Movement Record Maintenance - V 2.0

5.4 System Recording and Printing

  1. Ensure that all scanned and printed records are stored in the central database.
  2. Print hard copies of dispensing records and attach them to the respective BMR.
  3. Any errors in scanning or printing should be reported to the IT department immediately.

5.5 End-of-Process Checks

  1. Verify that all dispensed materials have valid, updated barcoded labels.
  2. Cross-check physical labels with system logs before transferring materials to production.
  3. Review system-generated logs and have them signed by the Production Supervisor and QA Officer.

6. Abbreviations

  • BMR: Batch Manufacturing Record
  • QA: Quality Assurance
  • GMP: Good Manufacturing Practice
  • SOP: Standard Operating Procedure

7. Documents

  1. Material Dispensing Log (Annexure-1)
  2. Certificate of Analysis (Annexure-2)
  3. Approval and Release Form (Annexure-3)
See also  Elixir Department: SOP for Labeling of Raw Materials During Dispensing - V 2.0

8. References

  • 21 CFR Part 11 – Electronic Records and Signatures
  • WHO GMP Guidelines for Pharmaceutical Production
  • EU GMP Annex 11 – Computerised Systems

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Dispensing Log

Date Material Batch No. Qty Dispensed Barcode Label ID Dispensed By
11/04/2025 Sodium Citrate SC9021 2.0 kg BC-041125-SC Rajesh Kumar

Annexure-2: Certificate of Analysis (CoA)

Material Batch No. Test Result Complies
Sodium Citrate SC9021 Assay 99.8% Yes

Annexure-3: Approval and Release Form

Date Material Batch No. Released By Approved By Remarks
11/04/2025 Sodium Citrate SC9021 Sunita Reddy Manoj Verma Approved

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Release New SOP Implementation QA Head
11/04/2025 2.0 System Enhancements and GMP Integration Barcode Automation QA Head
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