Standard Operating Procedure for Volume Adjustment Using Purified Water in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/103/2025 |
| Supersedes | SOP/ELX/103/2022 |
| 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 the final bulk volume of elixir formulations using Purified Water (PW) to meet specified batch volume as per the Master Formula Record (MFR).
2. Scope
This SOP is applicable to all elixir batches in the Elixir Department requiring final volume correction using Purified Water prior to filtration, sampling, or filling.
3. Responsibilities
- Production Operator:
- Carry out the volume adjustment operation and record quantities.
- Production Supervisor:
- Verify calculations, supervise adjustment, and authorize final volume.
- QA Officer:
- Review and approve adjusted volume, and ensure compliance with specifications.
4. Accountability
The Head of Production is accountable for ensuring correct and validated volume adjustment using Purified Water, and maintaining traceable documentation.
5. Procedure
5.1 Initial Checks
- Verify that mixing and in-process testing are complete.
- Ensure the manufacturing tank is
equipped with a calibrated volume measurement system (e.g., sight glass, scale, or flowmeter).
Check the current batch volume and compare with the target batch volume specified in the BMR.
5.2 Calculation of Required PW Volume
- Determine the difference between target and current volume:
Required PW Volume = Target Volume – Observed Volume - Document this calculation in the Volume Adjustment Log (Annexure-1).
- Ensure calculated PW addition does not exceed permitted limit defined in the product formula.
5.3 Volume Adjustment Process
- Ensure the PW line and connections are sanitized and labeled “READY FOR USE.”
- Open PW valve and allow slow addition of Purified Water into the tank under constant stirring.
- Monitor volume through the calibrated device and stop at the precise required level.
- Continue mixing for 15–20 minutes to ensure uniformity of the batch after volume adjustment.
5.4 Post-Adjustment Sampling
- Draw samples from the tank and send to QC for verification of assay, pH, alcohol content, and other critical parameters.
- Record sampling activity in the BMR and Sampling Log.
- Proceed only after QA approval of post-adjustment results.
5.5 Documentation
- Document all details including:
- Observed and final volumes
- PW volume added
- Mixing time
- Operator and supervisor signatures
- Attach the completed Volume Adjustment Log (Annexure-1) to the BMR.
5.6 Precautions
- Do not add PW after final QC sampling unless re-sampling is conducted and re-approved.
- Ensure all fittings and hoses used are dedicated and marked for PW handling.
6. Abbreviations
- SOP: Standard Operating Procedure
- PW: Purified Water
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
7. Documents
- Volume Adjustment Log (Annexure-1)
- Batch Manufacturing Record (BMR)
8. References
- WHO TRS 1019 – Good Manufacturing Practices for Pharmaceutical Products
- 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: Volume Adjustment Log
| Date | Batch No. | Target Volume (L) | Observed Volume (L) | PW Added (L) | Final Volume (L) | Adjusted By | Verified By |
|---|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1042 | 1000 | 975 | 25 | 1000 | 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 | Clarified mixing and sampling requirements post-adjustment | Process Control Enhancement | QA Head |