Elixir Department: SOP for Use of Approved Dispensing Aids and Equipment – V 2.0

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Elixir Department: SOP for Use of Approved Dispensing Aids and Equipment – V 2.0

Standard Operating Procedure for Use of Approved Dispensing Aids and Equipment

Department Elixir Department
SOP No. SOP/ELX/012/2025
Supersedes SOP/ELX/012/2022
Page No. Page 1 of 8
Issue Date 13/04/2025
Effective Date 15/04/2025
Review Date 13/04/2026

1. Purpose

To outline the procedure for the selection, use, and verification of approved dispensing aids and equipment in the Elixir Department to ensure accuracy, prevent contamination, and maintain compliance with cGMP guidelines.

2. Scope

This SOP applies to all tools, equipment, and accessories used during the dispensing of raw materials for elixir manufacturing in the dispensing area, including scoops, spatulas, balances, containers, weighing vessels, and laminar air flow units.

3. Responsibilities

  • Warehouse Operators:
    • Use only labeled and approved dispensing aids.
    • Ensure tools are cleaned, calibrated (if applicable), and in good condition.
  • Warehouse Supervisor:
    • Ensure availability of cleaned equipment.
    • Verify equipment status before each use.
  • QA Officer:
    • Audit usage and approve equipment before each batch if required.
See also  Elixir Department: SOP for Receiving of Raw Materials for Elixirs - V 2.0

4. Accountability

The Head of Warehouse and the Head of QA are accountable for ensuring that only qualified and approved dispensing equipment is used in material

handling operations.

5. Procedure

5.1 Selection of Dispensing Aids

  1. Select dispensing aids such as:
    • Stainless steel or polypropylene scoops
    • Spatulas, funnels, tongs
    • Weighing containers
    • Weighing boats or beakers
  2. Ensure all equipment is labeled with status tags: “Cleaned” or “To Be Cleaned.”
  3. Do not use damaged, cracked, or rusted tools.

5.2 Pre-Use Checks

  1. Check cleanliness, integrity, and label status of the equipment.
  2. Verify cleaning status log and last usage record (Annexure-1).
  3. For weighing balances:
    • Verify calibration sticker and due date.
    • Perform internal standard weight check if applicable.

5.3 Usage Guidelines

  1. Use designated scoops and containers for each material to avoid cross-contamination.
  2. Do not interchange aids between materials during a batch.
  3. Dispense materials under laminar air flow if required by SOP or material risk category.
  4. Keep unused aids on a clean tray or stand; avoid placing on floors or ledges.
See also  Elixir Department: SOP for Issuance of Raw Materials for Elixir Production - V 2.0

5.4 Post-Use Cleaning

  1. Clean all equipment immediately after use with purified water and detergent solution.
  2. Rinse thoroughly and dry in the designated drying area.
  3. Label as “Cleaned” with:
    • Date of Cleaning
    • Cleaned By
    • Verified By (QA/Designee)

5.5 Storage and Maintenance

  1. Store dispensing aids in designated cabinets, clearly marked for “Clean Equipment.”
  2. Keep dry and covered to prevent contamination.
  3. Record storage location and assignment in the Equipment Log (Annexure-2).

5.6 Equipment Qualification

  1. All weighing balances, laminar air flow cabinets, and other electronic aids shall be qualified as per the equipment qualification SOP.
  2. Log calibration and preventive maintenance as per schedule.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • cGMP: current Good Manufacturing Practices
See also  Elixir Department: SOP for Agitator Blade Changeover Procedure - V 2.0

7. Documents

  1. Cleaning and Use Record of Dispensing Aids (Annexure-1)
  2. Dispensing Equipment Log (Annexure-2)

8. References

  • 21 CFR Part 211 – Subpart D: Equipment and Facilities
  • WHO GMP – Cleaning and Equipment Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning and Use Record of Dispensing Aids

Equipment Name Cleaned On Used For Cleaned By Verified By Remarks
SS Scoop 12/04/2025 Sorbitol Rajesh Kumar Sunita Reddy Ready for Use

Annexure-2: Dispensing Equipment Log

Equipment ID Equipment Name Assigned Location Status Remarks
DSP-01 Analytical Balance Dispensing Room A Calibrated Due Next: 10/07/2025

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
10/01/2022 1.0 Initial Version New SOP QA Head
13/04/2025 2.0 Added qualification and preventive maintenance GMP Update QA Head
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