Standard Operating Procedure for Monitoring of Solvent Recovery Efficiency in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/048/2025 |
| Supersedes | SOP/API/048/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a consistent and standardized procedure for monitoring the efficiency of solvent recovery processes in API manufacturing, thereby ensuring optimal performance, resource conservation, and regulatory compliance.
2. Scope
This SOP applies to all solvent recovery operations within the API manufacturing facility where solvents are reclaimed through distillation or purification processes.
3. Responsibilities
- Production Team: Record input and output quantities of solvents used and recovered.
- Engineering Department: Ensure accurate performance of solvent recovery equipment.
- QA Department: Verify calculations and trend monitoring reports.
4. Accountability
The Production Head is accountable for capturing recovery data accurately. The QA Head is responsible for reviewing efficiency trends and identifying improvements.
5. Procedure
5.1 Data Recording
- Record the total quantity of fresh solvent charged during production (Q₁).
- Record the total volume of solvent collected post-recovery (Q₂).
- Maintain these entries in the “Solvent Recovery Efficiency Log” (Annexure-1).
- Ensure readings are captured immediately after recovery completion to avoid loss due to evaporation or handling.
5.2 Calculation of Recovery Efficiency
Use the following formula:
Solvent Recovery Efficiency (%) = (Q₂ / Q₁) × 100
- Calculate for each batch processed.
- Round off efficiency values to one decimal place.
- Log calculated efficiency and compare against standard benchmark for each solvent type (typically ≥85%).
5.3 Trend Analysis and Investigation
- QA shall review weekly solvent recovery efficiency data.
- Prepare monthly trend charts to assess:
- Recovery losses
- Batch-wise deviations
- Equipment performance
- In case recovery falls below threshold for three consecutive batches, initiate investigation and root cause analysis.
- Document CAPA (Corrective and Preventive Actions) where applicable.
5.4 Reporting and Documentation
- Compile monthly summary reports for management review.
- Attach solvent recovery efficiency data to batch manufacturing records where applicable.
- Submit efficiency reports during GMP inspections and audits if requested.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- Q₁: Quantity of fresh solvent used (L)
- Q₂: Quantity of solvent recovered (L)
- CAPA: Corrective and Preventive Action
7. Documents
- Solvent Recovery Efficiency Log (Annexure-1)
- Monthly Efficiency Trend Report (Annexure-2)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – Subpart J (Records and Reports)
- WHO GMP Guidelines – Section 9 (Self-inspection and Documentation)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Solvent Recovery Efficiency Log
| Date | Solvent | Q₁ (L) | Q₂ (L) | Efficiency (%) | Recorded By |
|---|---|---|---|---|---|
| 13/04/2025 | Acetone | 100 | 91 | 91.0 |
Annexure-2: Monthly Efficiency Trend Report
| Month | Solvent | Avg. Recovery (%) | Deviation | Remarks |
|---|---|---|---|---|
| April 2025 | Acetone | 89.5 | None | Within range |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | GMP Requirement | QA Head |
| 13/04/2025 | 2.0 | Added Trend Monitoring & Annexures | Process Optimization | QA Head |