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 |