Capsule: SOP for Ensuring Dispensing Accuracy Using Barcode Scanning – V 2.0

Posted on By

Capsule: SOP for Ensuring Dispensing Accuracy Using Barcode Scanning – V 2.0

Standard Operating Procedure for Ensuring Dispensing Accuracy Using Barcode Scanning

Department Capsule Manufacturing
SOP No. SOP/CM/015/2025
Supersedes SOP/CM/015/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

To establish a standardized procedure for using barcode scanning technology to ensure dispensing accuracy in capsule manufacturing, minimizing human errors and improving traceability.

2. Scope

This SOP applies to all dispensing operations in capsule manufacturing where materials, including APIs and excipients, are dispensed using barcode scanning technology.

3. Responsibilities

  • Manufacturing Personnel: Responsible for ensuring that all materials are accurately scanned before dispensing and for reporting any issues with the barcode scanning system.
  • Quality Control (QC) Team: Ensures that the barcode scanning system is calibrated, functional, and that the scanned data is verified for accuracy.
  • Quality Assurance (QA) Team: Monitors compliance with barcode scanning procedures and ensures that all dispensing activities are properly documented and traceable.
  • IT/Technical Support Team: Responsible for maintaining and troubleshooting the barcode scanning system, including ensuring system updates and software maintenance.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring that dispensing operations are performed using barcode scanning technology. The QA Manager is responsible for overseeing the accuracy and compliance of all scanning activities.

5. Procedure

5.1 Setting Up the Barcode Scanning System

Ensure the barcode scanning system is properly set up and functional before dispensing materials:

  1. System Calibration

    1. Ensure that barcode scanners are calibrated and functioning correctly. This includes checking the scanner’s focus, alignment, and connection to the dispensing system.
    2. Test the system by scanning a test barcode to verify that the system is able to read and record the data correctly.
  2. Software Configuration

    1. Ensure that the barcode scanning software is properly configured to integrate with the inventory and batch tracking system, linking each scanned material to the corresponding batch record.
    2. Verify that the software is updated with the correct material and batch information for all dispensable materials.
  3. Barcode Labeling

    1. Ensure that all raw materials, APIs, excipients, and packaging materials are properly labeled with unique barcodes that correspond to their material IDs and batch numbers.
    2. Confirm that the labels are legible and not damaged, and that they are affixed to the materials before they are brought into the dispensing area.
See also  Capsule: SOP for API and Excipient Compatibility Studies - V 2.0

5.2 Scanning Materials During Dispensing

Follow these steps to scan materials before dispensing:

  1. Pre-Dispensing Scan

    1. Before dispensing any material, scan the barcode on the material packaging to confirm the identity of the material.
    2. Verify that the scanned material matches the material listed in the work order and batch record.
  2. Scan for Dispensing

    1. Scan the material barcode again at the point of dispensing to log the quantity and confirm that the correct material is being dispensed into the appropriate container or equipment.
    2. Ensure that the barcode scan is successfully recorded in the system and matches the required quantity as per the work order.
  3. Confirm Dispensing Accuracy

    1. After scanning, compare the quantity dispensed with the quantity required as per the batch record. If there is any discrepancy, stop dispensing and resolve the issue before proceeding.
    2. Ensure that the system automatically updates the material stock levels in the inventory system to reflect the dispensed quantity.
See also  Capsule: SOP for Use of Personal Protective Equipment in Dispensing Areas - V 2.0

5.3 Post-Dispensing Verification

Ensure that the dispensing process is verified after each dispensing activity:

  1. Verify Scanning Data

    1. After dispensing, review the scanned data to ensure that the correct material and quantity were logged accurately in the system.
    2. Cross-check the scanned data with the batch record to ensure consistency between the physical materials dispensed and the system records.
  2. Address Discrepancies

    1. If discrepancies are found (e.g., incorrect quantity dispensed, material mismatch), investigate the cause immediately and document the findings in the Discrepancy Report (Annexure-1).
    2. Do not proceed with production or manufacturing until the issue is resolved and confirmed by the QA team.

5.4 Barcode Scanning System Maintenance

Ensure that the barcode scanning system is maintained regularly to ensure ongoing accuracy:

  1. Routine System Checks

    1. Perform routine checks on the barcode scanners to ensure they are clean, functional, and calibrated correctly.
    2. Perform software updates and backups as per the IT department’s schedule to ensure the system runs smoothly and is up to date.
  2. Training on Barcode Scanning

    1. Provide training to all relevant personnel on the proper use of the barcode scanning system, including how to handle scanner malfunctions or misreads.
    2. Conduct periodic refresher training sessions to ensure ongoing compliance with barcode scanning procedures.

5.5 Documentation and Record-Keeping

Ensure proper documentation for all barcode scanning activities to maintain traceability and compliance:

  1. Material Dispensing Log

    1. Document all barcode scan results in the Material Dispensing Log (Annexure-2), including the material name, batch number, quantity dispensed, date, and personnel involved in scanning and dispensing.
    2. Ensure that all scanning errors or issues are documented and addressed in the system with corrective actions recorded in the Discrepancy Report (Annexure-1).
  2. Audit Trail

    1. Ensure that an audit trail is maintained in the system to allow traceability of all scanned data for future audits and inspections.
    2. Ensure that audit logs include time stamps and user details for each scanning activity performed.
See also  Capsule: SOP for Preparing Development Reports for Capsule Dosage Forms - V 2.0

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • API: Active Pharmaceutical Ingredient
  • PO: Purchase Order
  • CoA: Certificate of Analysis

7. Documents

  1. Material Dispensing Log (Annexure-2)
  2. Discrepancy Report (Annexure-1)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Discrepancy Report

Date Material Name Batch Number Issue Description Corrective Action
03/02/2025 API-123 Batch 56789 Barcode misread Re-scanned and verified with corrected quantity

Annexure-2: Material Dispensing Log

Date Material Name Batch Number Quantity Dispensed Scanned By
03/02/2025 Excipient-456 Batch 12345 100 g John Doe

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated barcode scanning procedures Standardization QA Head
Capsules V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , , , , , ,