Elixir Department: SOP for Dispensing Solvents and Vehicles – V 2.0

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Elixir Department: SOP for Dispensing Solvents and Vehicles – V 2.0

Standard Operating Procedure for Dispensing Solvents and Vehicles in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/029/2025
Supersedes SOP/ELX/029/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define a standard method for safe, accurate, and contamination-free dispensing of solvents and vehicles used in the manufacturing of oral liquid elixirs, ensuring consistency, traceability, and compliance with cGMP and regulatory guidelines.

2. Scope

This SOP applies to the dispensing of all solvents and vehicles including purified water, ethanol, glycerin, propylene glycol, and other approved liquid carriers used in the Elixir Department.

3. Responsibilities

  • Warehouse Assistant:
    • Verify material approval status and transport materials to the dispensing area.
    • Ensure clean and labeled containers are used.
  • Dispensing Operator:
    • Perform accurate measurement and labeling.
    • Maintain cleanliness and prevent cross-contamination.
  • Production Pharmacist:
    • Supervise the dispensing process and verify accuracy.
  • Quality Assurance (QA):
    • Review documentation and approve the release of dispensed materials.
See also  Elixir Department: SOP for Environmental Conditions for Dispensing of Elixirs - V 2.0

4. Accountability

The Head of the Elixir Department is accountable for the implementation and compliance of this SOP and ensuring that all dispensing procedures follow current GMP practices.

5. Procedure

5.1 Requisition and Verification

  1. Verify the Bill of Materials (BoM) and Manufacturing Batch Record (MBR) to identify required solvents/vehicles and their quantities.
  2. Generate a material requisition slip and ensure approval from the Production Head.
  3. Ensure the material is approved by QC and bears the green ‘Approved’ label.

5.2 Transfer to Dispensing Area

  1. Transport the container to the dispensing booth using a clean, dedicated trolley.
  2. Ensure the dispensing booth is clean and meets differential pressure requirements.
  3. Check the label for:
    • Material Name
    • Batch Number
    • Manufacturing/Expiry Date
    • Storage Conditions

5.3 Dispensing Process

  1. Ensure that the receiving container is dry, clean, and labeled.
  2. Use a calibrated measuring cylinder, flow meter, or balance (as appropriate) for measurement.
  3. Dispense the required quantity as per batch record. Avoid spillage or splash during transfer.
  4. Seal the dispensed container immediately and affix a ‘Dispensed’ label with:
    • Material Name
    • Batch Number
    • Quantity Dispensed
    • Date
    • Dispensed By
See also  Elixir Department: SOP for Reconciliation of Raw Materials Post Dispensing - V 2.0

5.4 Special Considerations

  1. For flammable solvents (e.g., ethanol), ensure that proper grounding and fire safety precautions are taken.
  2. Use appropriate PPE including chemical-resistant gloves, apron, goggles, and mask.
  3. Ensure that the solvent is compatible with the material of the container used for dispensing.

5.5 Documentation and Release

  1. Record the details of the activity in the Material Dispensing Log (Annexure-1).
  2. Attach the Certificate of Analysis (Annexure-2) for each solvent batch used.
  3. Fill out the Approval and Release Form (Annexure-3) and submit to QA.

6. Abbreviations

  • BoM: Bill of Materials
  • MBR: Manufacturing Batch Record
  • QA: Quality Assurance
  • QC: Quality Control
  • PPE: Personal Protective Equipment
  • 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)

8. References

  • 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
  • ICH Q7 – GMP for APIs
  • WHO GMP Guide – Pharmaceutical Production
See also  Elixir Department: SOP for Cleaning Verification Procedure After Dispensing - V 2.0

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 Solvent/Vehicle Batch No. Qty Dispensed Dispensed By Verified By
11/04/2025 Ethanol ETH9901 10.0 L Rajesh Kumar Sunita Reddy
11/04/2025 Purified Water PW7723 50.0 L Ajay Mehta Kiran Joshi

Annexure-2: Certificate of Analysis (CoA)

Material Batch No. Test Parameter Result Complies
Ethanol ETH9901 Purity 99.8% Yes
Purified Water PW7723 Conductivity 1.0 µS/cm Yes

Annexure-3: Approval and Release Form

Date Material Batch No. Released By Approved By Status
11/04/2025 Ethanol ETH9901 Sunita Reddy Manoj Verma Approved
11/04/2025 Purified Water PW7723 Kiran Joshi Manoj Verma Approved

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Issuance New SOP QA Head
11/04/2025 2.0 Updated Format, Added PPE Instructions Standardization QA Head
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