Standard Operating Procedure for Verification of Final Product Volume in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/098/2025 |
| Supersedes | SOP/ELX/098/2022 |
| 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 standardized procedure for the verification of final batch volume of elixir formulations prior to release for filling or storage to ensure accuracy, compliance, and product integrity.
2. Scope
This SOP applies to the final volume verification step carried out after completion of mixing and before filtration or filling of elixir batches in the Elixir Department.
3. Responsibilities
- Production Operator:
- Measure and record the final batch volume as per SOP.
- Production Supervisor:
- Verify the volume measurement and approve it for documentation in the BMR.
- QA Officer:
- Ensure batch volume is within permissible deviation and approve for next stage.
4. Accountability
The Head of Production is accountable for ensuring accurate verification of final batch volume and compliance with specifications.
5. Procedure
5.1 Equipment and Calibration
- Use a pre-calibrated
measuring tank or a metered sight glass system to measure volume.
Ensure all measuring equipment is calibrated and labeled with calibration status.
Record equipment ID and calibration date in the Volume Verification Log (Annexure-1).
5.2 Volume Measurement Process
- Ensure that the batch is completely mixed and free of foam before measuring volume.
- Stop agitation, allow the solution to settle for 5 minutes to eliminate froth and bubbles.
- Check the volume reading on the calibrated sight glass or volume scale of the vessel.
- Record the final observed volume along with batch number, date, and time.
5.3 Permissible Deviation
- The final volume should not deviate more than ±2% from the target batch volume as per the BMR.
- If deviation exceeds this limit, report to QA and investigate for possible evaporation loss, spillage, or over-dilution.
5.4 Documentation
- Record the final verified volume in the Volume Verification Log and BMR.
- Supervisor to verify and sign against the recorded value.
- QA to review and approve volume verification before authorizing the next step.
5.5 Special Instructions
- Do not adjust volume using purified water after final alcohol assay unless approved by QA and documented as adjustment.
- In case of product holding post-volume verification, ensure container is closed and labeled appropriately.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
7. Documents
- Volume Verification Log (Annexure-1)
- Batch Manufacturing Record (BMR)
- Deviation Report (if applicable)
8. References
- 21 CFR Part 211.103 – Calculation of Yield
- WHO TRS 1019 – GMP for Pharmaceutical Products
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 Verification Log
| Date | Batch No. | Target Volume (L) | Final Volume Observed (L) | Deviation (%) | Observed By | Verified By |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1037 | 1000 | 985 | -1.5% | 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 | Included updated deviation thresholds and settling instruction | Process Optimization | QA Head |