Elixir Department: SOP for Alcohol Content Estimation (Intermediate) – V 2.0

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Elixir Department: SOP for Alcohol Content Estimation (Intermediate) – V 2.0

Standard Operating Procedure for Alcohol Content Estimation During Intermediate Stages in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/196/2025
Supersedes SOP/ELX/196/2022
Page No. Page 1 of 9
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To describe the procedure for determining alcohol content at intermediate stages during elixir manufacturing using validated analytical techniques to ensure product consistency and compliance with regulatory standards.

2. Scope

This SOP is applicable to in-process alcohol content testing conducted after the addition of alcohol and prior to final blending, filtration, or packaging for all elixirs manufactured in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Collect intermediate samples for alcohol testing and forward them to QC.
  • QC Analyst:
    • Perform alcohol content testing using the specified method (e.g., GC or specific gravity method).
    • Record and report results to QA and Production.
  • QA Officer:
    • Review the test results and approve continuation of the batch.
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4. Accountability

The QC Head is accountable for accuracy of test results. The Production Head is responsible for ensuring timely sampling. QA Head is responsible for compliance and final release

decisions.

5. Procedure

5.1 Sampling for Alcohol Estimation

  1. Collect 50–100 mL of elixir sample after the alcohol addition step is completed and the batch is uniformly mixed.
  2. Use a clean, dry, amber glass vial labeled with:
    • Product name
    • Batch number
    • Sampling time
    • “Alcohol Estimation Sample”
  3. Ensure sampling is performed away from heating or volatile zones and under a fume hood if required.

5.2 Analytical Methodology

  1. Test shall be conducted using one of the following methods:
    • Gas Chromatography (GC): Primary validated method for high-accuracy measurement.
    • Specific Gravity Comparison: For quick estimation using pycnometer and alcohol tables.
  2. Follow SOP/QA/GC/001 for GC procedure and SOP/QC/SG/002 for specific gravity method.
  3. Run the system suitability with standard ethanol solutions before sample analysis.
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5.3 Calculation and Interpretation

  1. Calculate alcohol percentage as v/v using validated formula or software report.
  2. Compare the result with the in-process specification defined in the BMR (e.g., 12.0% – 14.0% v/v).
  3. Acceptable deviation should not exceed ±0.5% of the target value unless otherwise specified in product dossier.

5.4 Actions for Out-of-Specification (OOS) Results

  1. Notify QA immediately and quarantine the batch.
  2. Perform repeat testing using retained sample and freshly collected sample.
  3. Initiate deviation form and follow CAPA if OOS is confirmed.

5.5 Documentation

  1. Enter results in the Alcohol Estimation Logbook (Annexure-1).
  2. Attach chromatograms or data printouts to the QC worksheet.
  3. QA must review and sign off the test report before batch continuation.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • GC: Gas Chromatography
  • OOS: Out of Specification
  • CAPA: Corrective and Preventive Action
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7. Documents

  1. Alcohol Estimation Logbook (Annexure-1)
  2. Batch Manufacturing Record (BMR)
  3. Analytical Test Procedure (GC or SG)

8. References

  • ICH Q2(R1) – Validation of Analytical Procedures
  • 21 CFR Part 211.160 – Laboratory Controls
  • Pharmacopoeial Monographs (USP/BP) for Ethanol Estimation

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 Estimation Logbook

Date Batch No. Method Used Result (% v/v) Specification Tested By QA Verified
11/04/2025 ELX-0425-015 GC 13.4 12.0 – 14.0 Rajesh Kumar Sunita Reddy

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 Included specific gravity method and deviation handling GMP Update QA Head
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