Standard Operating Procedure for Addition of Volatile and Flavoring Agents in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/062/2025 |
| Supersedes | SOP/ELX/062/2022 |
| 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 controlled addition of volatile ingredients and flavoring agents in elixir manufacturing to maintain sensory quality, dosage uniformity, and product stability.
2. Scope
This SOP applies to the addition of volatile solvents (e.g., ethanol) and flavoring substances (natural or artificial) to elixir batches manufactured in the Elixir Department.
3. Responsibilities
- Production Operator:
- Handle and add volatile/flavoring agents per BMR instructions.
- Ensure closed-system transfer where applicable.
- Production Supervisor:
- Verify material identity, addition quantity, and compliance with safety protocols.
- QA Officer:
- Monitor handling and addition process, and sign off final verification.
4. Accountability
The Production Head is accountable for ensuring that volatile and flavoring agents are added under controlled conditions and in accordance with the BMR.
5. Procedure
5.1 Pre-Addition Requirements
- Ensure batch mixing is complete
and the solution is cooled to below 30°C before addition of volatile/flavoring agents.
Check and confirm the material labels, batch numbers, and expiry dates against the BMR.
Transfer materials to the manufacturing area only after QA release.
5.2 Addition Procedure
- Use a closed funnel or peristaltic pump to add volatile agents (e.g., ethanol) to prevent evaporation loss.
- Introduce flavoring agents directly into the vortex of the agitating batch.
- Continue mixing at moderate speed (50–80 RPM) for a minimum of 15 minutes post-addition.
- Ensure the tank lid is closed throughout the process to reduce volatilization.
5.3 Safety Measures
- Use PPE (gloves, mask, goggles) while handling alcohol-based or volatile ingredients.
- Ensure local exhaust ventilation is operational in the addition area.
- Avoid open flames or sources of ignition in proximity to the materials.
5.4 Documentation
- Enter details of quantity, time, temperature, and material in the Flavor & Volatile Addition Log (Annexure-1).
- Cross-verify with supervisor and attach to the BMR.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Flavor & Volatile Addition Log (Annexure-1)
- Batch Manufacturing Record
- Material Usage Authorization Form (Annexure-2)
8. References
- WHO TRS 961 Annex 3 – GMP Guidelines for Pharmaceutical Liquids
- 21 CFR 211.113 – Control of Microbial Contamination
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Flavor & Volatile Addition Log
| Date | Batch No. | Material Name | Quantity (mL) | Time of Addition | Temperature (°C) | Added By | Verified By |
|---|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1008 | Orange Flavor | 150 | 11:30 AM | 28 | Rajesh Kumar | Sunita Reddy |
| 11/04/2025 | ELX-1008 | Ethanol IP | 500 | 11:45 AM | 28 | Rajesh Kumar | Sunita Reddy |
Annexure-2: Material Usage Authorization Form
| Date | Material | Batch No. | Approved Quantity | Authorized By | Remarks |
|---|---|---|---|---|---|
| 11/04/2025 | Ethanol IP | ETH/0425 | 500 mL | Manju Sharma | For Batch ELX-1008 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Issue | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added Closed System and Safety Instructions | Process Safety Update | QA Head |