Standard Operating Procedure for Maintaining Volume Adjustments in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/059/2025 |
| Supersedes | SOP/ELX/059/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a standard procedure for accurately adjusting the final volume of elixir formulations during manufacturing to ensure batch consistency and compliance with quality specifications.
2. Scope
This SOP is applicable to all elixir batches manufactured in the Elixir Department where volume adjustments are required after addition and mixing of all components, prior to bulk filtration or filling.
3. Responsibilities
- Manufacturing Operator:
- Perform final volume adjustments using purified water or vehicle as specified.
- Document all adjustment details in the BMR and Volume Adjustment Log.
- Production Supervisor:
- Verify volume marking, tank calibration, and authorize adjustment.
- QA Officer:
- Cross-verify batch volume, perform visual checks, and sign off on final volume.
4. Accountability
The Production Head is accountable for ensuring that volume adjustments are performed correctly and documented to ensure batch uniformity.
5. Procedure
5.1 Pre-Adjustment Checks
- Ensure
that all ingredients (API, solvents, sweeteners, preservatives, flavors, etc.) have been added and mixed completely as per the BMR.
Stop the agitator and allow bubbles to settle before taking volume readings.
Check the calibrated volume graduation mark on the tank or use a dipstick (calibrated rod) if required.
5.2 Adjustment Procedure
- Determine the shortfall in volume from the target batch size (e.g., 100 L).
- Prepare the adjustment liquid (purified water or vehicle as specified) in a clean container.
- Restart slow agitation (e.g., 40–60 RPM).
- Slowly add the adjustment liquid while mixing until the final desired volume is reached.
- Stop addition immediately upon reaching target volume.
5.3 Post-Adjustment Verification
- Take samples from top, middle, and bottom and perform:
- Visual inspection (clarity, color, consistency)
- pH check (if applicable)
- Record observations and volume details in the Volume Adjustment Log (Annexure-1).
- Get verification from Supervisor and QA before proceeding to filtration or storage.
5.4 Documentation
- Enter all adjustment details (pre-volume, added volume, final volume, date, and time) in the BMR.
- Attach the signed Volume Adjustment Log to the BMR set.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- RPM: Revolutions Per Minute
7. Documents
- Volume Adjustment Log (Annexure-1)
- Tank Calibration Certificate (Annexure-2)
- Volume Verification Checklist (Annexure-3)
8. References
- WHO TRS 961 Annex 3 – GMP for Liquid Oral Preparations
- 21 CFR Part 211.101 – Production and Process Controls
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Volume Adjustment Log
| Date | Batch No. | Pre-Volume (L) | Adjustment Volume (L) | Final Volume (L) | Adjusted By | Verified By |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1005 | 95.0 | 5.0 | 100.0 | Rajesh Kumar | Sunita Reddy |
Annexure-2: Tank Calibration Certificate
| Tank ID | Calibrated On | Calibrated By | Next Due |
|---|---|---|---|
| TNK-ELX-07 | 01/02/2025 | Vikram Chauhan | 01/02/2026 |
Annexure-3: Volume Verification Checklist
| Checkpoint | Status | Remarks | Checked By |
|---|---|---|---|
| Pre-Volume Measured Correctly | Yes | Verified by dipstick | Sunita Reddy |
| Adjustment Volume Added | Yes | No deviation | Sunita Reddy |
| Final Volume Achieved | Yes | Exactly 100.0 L | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Issuance | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added Dipstick and Checklist Verification | Process Improvement | QA Head |