Elixir Department: SOP for Alcohol Strength Adjustment in Final Product – V 2.0

Auditor

8 months ago

Standard Operating Procedure for Alcohol Strength Adjustment in Final Elixir Product

Department	Elixir Department
SOP No.	SOP/ELX/097/2025
Supersedes	SOP/ELX/097/2022
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 adjusting alcohol content in the final elixir formulation to meet the specified strength as per product specification and regulatory guidelines.

2. Scope

This SOP applies to the alcohol strength adjustment activities carried out during or after the final mixing of elixir formulations in the Elixir Department prior to bulk storage or filling.

3. Responsibilities

Production Operator:
- Perform alcohol addition under supervision and record the activity accurately.
Production Supervisor:
- Verify calculations and supervise alcohol addition steps.
QA Officer:
- Verify final assay reports and approve the adjusted batch for release.

4. Accountability

The Head of Production is accountable for ensuring all alcohol strength adjustments are executed in a controlled, documented, and compliant manner.

5. Procedure

5.1 Pre-Adjustment Requirements

Ensure the batch is completely mixed and ready for

final testing.

Draw a representative sample and send to QC for alcohol content assay.

Await QC result before initiating any adjustment.

5.2 Determination of Adjustment Volume

If alcohol strength is outside the specified limit (±5% of label claim), calculate required volume of alcohol to be added or diluted.
Use the following formula for alcohol addition:
Required Volume = (Target% – Observed%) × Batch Volume / Alcohol Concentration (%)
Have all calculations verified and signed by supervisor and QA.

5.3 Alcohol Addition

Transfer calculated volume of ethanol or isopropyl alcohol (as per product requirement) using calibrated measuring cylinder or metering pump.
Add alcohol gradually under continuous stirring in a closed system.
Ensure mixing continues for at least 15–30 minutes after addition to achieve uniform distribution.

5.4 Post-Adjustment Sampling

Draw a fresh sample and send to QC for alcohol assay and confirmation of compliance with product specification.
Do not proceed to packing unless assay confirms the final alcohol content is within the approved range.

5.5 Documentation

Document adjustment details including:
- Initial alcohol assay result
- Target strength
- Volume added or removed
- Method used
- Final assay result
Use the Alcohol Adjustment Log (Annexure-1).
Attach adjustment record to the BMR and submit to QA for review.

5.6 Precautions

Only trained personnel should handle alcohols due to flammability and volatility.
Perform adjustments in a well-ventilated area with flame-proof equipment.
Ensure addition is within batch-specific limits to avoid batch rejection.

6. Abbreviations

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

7. Documents

Alcohol Adjustment Log (Annexure-1)
Batch Manufacturing Record (BMR)
Alcohol Assay Report

8. References

IP/USP Monographs for Ethanol/Isopropyl Alcohol
21 CFR Part 211.103 – Calculation of Yield
ICH Q8 – Pharmaceutical Development

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 Adjustment Log

Date	Batch No.	Initial Strength (%)	Target Strength (%)	Volume Adjusted (L)	Final Result (%)	Operator	Verified By
11/04/2025	ELX-1036	9.2%	10.0%	15.0 L	10.1%	Rajesh Kumar	Sunita Reddy

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial SOP Release	New SOP	QA Head
11/04/2025	2.0	Added calculation formula and updated safety instructions	Process Enhancement	QA Head