Elixir Department: SOP for Dispensing of Raw Materials for Elixirs – V 2.0

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Elixir Department: SOP for Dispensing of Raw Materials for Elixirs – V 2.0

Standard Operating Procedure for Dispensing of Raw Materials for Elixirs

Department Elixir Department
SOP No. SOP/ELX/005/2025
Supersedes SOP/ELX/005/2022
Page No. Page 1 of 9
Issue Date 13/04/2025
Effective Date 15/04/2025
Review Date 13/04/2026

1. Purpose

To lay down the procedure for accurate and GMP-compliant dispensing of raw materials used in the manufacturing of elixirs to ensure correct quantities, avoid contamination, and maintain traceability.

2. Scope

This SOP applies to the dispensing of all raw materials including active pharmaceutical ingredients (APIs), excipients, and solvents used for manufacturing elixirs in the Elixir Department.

3. Responsibilities

  • Warehouse Staff:
    • Perform material dispensing as per batch requirements.
    • Ensure accuracy in weighing and documentation.
  • Production Supervisor:
    • Verify dispensed quantities and labels.
  • QA Personnel:
    • Perform line clearance before dispensing.
    • Verify material identity, cleanliness of area, and labels.

4. Accountability

The Head of Warehouse and Head of Quality Assurance are accountable for ensuring that the dispensing activity is accurate, traceable, and performed in accordance with GMP.

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5. Procedure

5.1 Pre-Dispensing Checks

  1. Ensure dispensing area is cleaned
and cleared by QA (line clearance checklist).
  • Confirm the weighing balance calibration status.
  • Review the batch manufacturing record (BMR) and material requisition form for:
    • Material Name and Code
    • Batch No.
    • Required Quantity
    • Storage Conditions

    • 5.2 Material Selection

    1. Select materials from the approved storage zone only.
    2. Verify each container’s label for:
      • “Approved” status
      • Material name and code
      • Manufacturer/Supplier
      • Batch Number
      • Expiry/Re-test Date

    5.3 Dispensing Activity

    1. Use clean, pre-labeled dispensing containers with lids.
    2. Place containers on the calibrated balance and tare the weight.
    3. Weigh the required quantity as specified in the BMR using the correct balance (analytical for < 10g; precision for 10g–5kg; platform for >5kg).
    4. Record the actual quantity weighed on the Material Dispensing Log (Annexure-1).
    5. Affix the dispensing label (Annexure-2) with:
      • Material name and code
      • Batch No.
      • Quantity dispensed
      • Dispensing date
      • Signatures of operator and checker

    5.4 Labeling and Segregation

    1. Use color-coded labels (yellow for active, green for excipients, red for solvents).
    2. Keep dispensed materials in segregated bins for each batch to avoid mix-ups.

    5.5 Post-Dispensing

    1. Return unused original containers to the approved storage area.
    2. Label them as “Opened – In Use” with date of opening and initials.
    3. Update the stock ledger with the new balance.
    4. Ensure the weighing balance and dispensing platform are cleaned and recorded.

    5.6 QA Verification

    1. QA shall verify:
      • Correctness of material name and batch number
      • Quantity dispensed vs. BMR
      • Cleanliness of containers
      • Label accuracy
    2. Sign off on the Material Dispensing Log.

    6. Abbreviations

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

    7. Documents

    1. Material Dispensing Log (Annexure-1)
    2. Dispensing Label Format (Annexure-2)
    3. Balance Calibration Record
    4. Line Clearance Checklist

    8. References

    • 21 CFR Part 211 – Subpart E: Control of Components
    • WHO GMP Guidelines – Section on Dispensing and Weighing
    • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

    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 Name Batch No. Required Qty Dispensed Qty Dispensed By Checked By
    13/04/2025 Propylene Glycol PG0425B 10.0 kg 10.02 kg Rajesh Kumar Sunita Reddy

    Annexure-2: Dispensing Label

    Material Name Batch No. Code Qty Dispensed Date Operator Checker
    Propylene Glycol PG0425B RM-PG-003 10.02 kg 13/04/2025 Rajesh Kumar Sunita Reddy

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    10/01/2022 1.0 Initial SOP Release New SOP QA Head
    13/04/2025 2.0 Updated procedural clarity and added annexures GMP Compliance QA Head
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