SOP Guide for Pharma

Elixir Department: SOP for Label Generation and Application in Dispensing – V 2.0

Auditor

Elixir Department: SOP for Label Generation and Application in Dispensing – V 2.0

Standard Operating Procedure for Label Generation and Application During Material Dispensing

Department Elixir Department
SOP No. SOP/ELX/041/2025
Supersedes SOP/ELX/041/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

This SOP outlines the procedure for generation, printing, verification, and application of labels during the dispensing of materials in the Elixir Department, ensuring proper identification, traceability, and regulatory compliance.

2. Scope

This SOP applies to all raw materials, excipients, solvents, and active ingredients dispensed for elixir manufacturing. It covers computer-generated label creation, manual backup procedures, and affixing processes.

3. Responsibilities

  • Dispensing Operator:
    • Generate and print correct labels after dispensing activity.
    • Affix labels neatly and legibly to all dispensed containers.
  • Supervisor:
    • Verify label content for correctness before release.
  • QA Personnel:
    • Audit label format and details for accuracy and compliance.

4. Accountability

The Production Head is accountable for implementation of this SOP and ensuring labels are generated and applied correctly to avoid mix-ups and ensure traceability.

See also  Elixir Department: SOP for Control and Use of Primary Containers During Dispensing - V 2.0

5. Procedure

5.1 Label Format

  1. All dispensing
labels must contain the following:
  • Material Name
  • Material Code (if applicable)
  • Batch Number
  • Quantity Dispensed
  • Dispensed Date
  • Container Number (e.g., 1 of 3)
  • Dispensed By / Verified By
  • Status (e.g., Approved, Quarantine, Rejected)
  • The label size and font must be readable from a minimum distance of 1 meter.

    • 5.2 Label Generation

    1. Log into the Label Management System using individual credentials.
    2. Select the correct template based on the material type (API, excipient, solvent, etc.).
    3. Enter batch number, quantity, and container details as per BMR/MRF.
    4. Print labels using a barcode-enabled label printer. Retain one copy in the batch record file.

    5.3 Manual Labeling (Backup)

    1. In case of system failure, use pre-approved label templates available in the dispensing area.
    2. Fill in details legibly using a permanent marker. QA shall verify and sign the handwritten label.
    3. Replace with system-generated labels once system is restored.

    5.4 Label Application

    1. Affix the label on the front face of the container, avoiding folded or obscured placement.
    2. Ensure labels are:
      • Clean
      • Straight
      • Intact (not torn or peeling)
    3. Do not reuse damaged or used labels.

    5.5 Label Verification

    1. Before transferring dispensed materials, the supervisor must verify the following:
      • Label matches BMR and Dispensing Log
      • Correct container number and total quantity
      • Legibility and accuracy of text and barcode
    2. QA shall verify a sample of the printed labels during batch release audit.

    6. Abbreviations

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

    7. Documents

    1. Label Logbook (Annexure-1)
    2. Printed Label Template (Annexure-2)
    3. Label Verification Checklist (Annexure-3)

    8. References

    • 21 CFR Part 211 – GMP for Finished Pharmaceuticals
    • EU GMP – Chapter 4: Documentation
    • WHO GMP Guidelines – Labeling Requirements

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Label Logbook

    Date Material Name Batch No. Qty Container Nos. Label Generated By
    11/04/2025 Sodium Citrate SC2288 5.0 kg 1 of 2, 2 of 2 Rajesh Kumar

    Annexure-2: Printed Label Template

    Label Format Example
    Material: Sodium Citrate
    Batch No.: SC2288
    Qty Dispensed: 2.5 kg
    Container No.: 1 of 2
    Date: 11/04/2025
    Dispensed By: RK
    Verified By: SR

    Annexure-3: Label Verification Checklist

    Checklist Item Status (✓/✗) Verified By
    Correct Material Name ✓ Sunita Reddy
    Correct Batch No. ✓ Sunita Reddy
    Label Legible and Intact ✓ Sunita Reddy
    Matching Qty with BMR ✓ Sunita Reddy

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial Version New SOP Document QA Head
    11/04/2025 2.0 Template Revised and Annexures Added Standardization and Compliance QA Head
    See also  Elixir Department: SOP for Use of Personal Protective Equipment (PPE) in Dispensing Room - V 2.0
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