SOP Guide for Pharma

Elixir Department: SOP for Preparation of Alcohol-Based Elixirs – V 2.0

Auditor

Elixir Department: SOP for Preparation of Alcohol-Based Elixirs – V 2.0

Standard Operating Procedure for Preparation of Alcohol-Based Elixirs

Department Elixir Department
SOP No. SOP/ELX/066/2025
Supersedes SOP/ELX/066/2022
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 the procedure for the preparation of alcohol-based elixirs, including handling of alcohol, blending with aqueous phases, and ensuring uniformity and compliance with regulatory requirements.

2. Scope

This SOP applies to the manufacturing process of all elixir formulations containing ethanol or other pharmaceutically accepted alcohols in the Elixir Department.

3. Responsibilities

  • Manufacturing Operator:
    • Carry out the preparation, mixing, and temperature control during alcohol addition.
    • Ensure proper sealing and fire safety during handling of alcohol.
  • Production Supervisor:
    • Verify batch documentation and ensure adherence to addition sequence and temperature control.
  • QA Officer:
    • Monitor the process, check for homogeneity, and ensure compliance with GMP.

4. Accountability

The Production Head is accountable for the correct execution of alcohol-based elixir preparation and documentation.

See also  Elixir Department: SOP for Use of Jacketed Vessels - V 2.0

5. Procedure

5.1 Pre-Preparation Checks

  1. Ensure that the mixing tank is clean and labeled as “CLEANED.”
  2. Check and
verify the identity and quantity of ethanol/alcohol with the dispensing log and CoA.
  • Ensure exhaust ventilation, flame-proof electrical fittings, and availability of fire extinguishers.

    • 5.2 Preparation of Aqueous Phase

    1. In a clean mixing vessel, prepare the aqueous phase by dissolving water-soluble components such as preservatives, sweeteners, colorants, and API (if applicable).
    2. Mix until all solids are dissolved completely.

    5.3 Alcohol Addition Procedure

    1. Ensure the temperature of the aqueous phase is below 30°C before alcohol addition.
    2. Slowly add ethanol/alcohol under continuous stirring to avoid localized concentration and vaporization.
    3. Use a closed addition funnel or pump to avoid vapor release.
    4. Continue agitation for at least 30 minutes to ensure uniform blending.

    5.4 Volume Make-up

    1. Adjust the final volume with purified water to the batch size as per BMR.
    2. Stir for an additional 10–15 minutes.

    5.5 In-process Checks

    1. Take samples for pH, appearance, and alcohol content (as per STP).
    2. Document observations and results in the BMR and Alcohol Elixir Log (Annexure-1).

    5.6 Safety Precautions

    1. Always handle alcohol away from sources of ignition or heat.
    2. Use flame-proof lighting and ensure operators wear PPE, including gloves and eye protection.
    3. Store unused alcohol in flammable material storage cabinets with proper labeling.

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • BMR: Batch Manufacturing Record
    • QA: Quality Assurance
    • CoA: Certificate of Analysis
    • PPE: Personal Protective Equipment

    7. Documents

    1. Alcohol Elixir Log (Annexure-1)
    2. Fire Safety Checklist (Annexure-2)
    3. Material Usage Log for Ethanol (Annexure-3)

    8. References

    • 21 CFR Part 210 & 211 – GMP for Finished Pharmaceuticals
    • WHO TRS 961 Annex 3 – GMP for Liquid Dosage Forms
    • NF/USP Monographs on Ethanol

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Alcohol Elixir Log

    Date Batch No. Alcohol Quantity (mL) Added By Mixing Time (min) Verified By
    11/04/2025 ELX-1011 5000 Rajesh Kumar 30 Sunita Reddy

    Annexure-2: Fire Safety Checklist

    Area Fire Extinguisher Present Ventilation On Flammable Signs Visible Checked By
    Mixing Room Yes Yes Yes Manju Sharma

    Annexure-3: Material Usage Log for Ethanol

    Date Material Name Batch No. Quantity Issued Used In Batch Balance
    11/04/2025 Ethanol IP ETH-0325 6000 mL ELX-1011 1000 mL

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial Release New SOP QA Head
    11/04/2025 2.0 Inclusion of safety protocols and updated annexures Process Standardization QA Head
    See also  Elixir Department: SOP for Cleaning of Dispensing Area Before and After Use - V 2.0
    Exit mobile version