Standard Operating Procedure for Documentation and Yield Calculation for Solvent Recovery in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/050/2025 |
| Supersedes | SOP/API/050/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define the procedure for documentation and yield calculation related to solvent recovery operations in the API manufacturing process, ensuring traceability, data integrity, and process optimization.
2. Scope
This SOP applies to all recovered solvents generated through distillation or purification processes in API manufacturing and includes data logging, reconciliation, and yield calculation activities.
3. Responsibilities
- Production Operator: Record raw and recovered solvent volumes accurately.
- Shift Supervisor: Review calculations and authorize entries.
- QA Department: Verify and audit solvent yield documentation.
4. Accountability
The Production Head is accountable for ensuring the correctness of documentation and yield calculations. The QA Head is responsible for compliance and review.
5. Procedure
5.1 Data Recording
- Record the following in the “Solvent Recovery Log” (Annexure-1) for each recovery operation:
- Batch Number
- Solvent Type
- Volume of solvent used (Input)
- Volume of solvent recovered (Output)
- Date and Time of recovery
- Ensure equipment ID and operator initials are also logged.
5.2 Yield Calculation
- Use the following formula for solvent recovery yield:
Solvent Recovery Yield (%) = (Volume Recovered / Volume Used) × 100
- Calculate and record yield on the same log sheet.
- Round off to one decimal place and document in the “Yield Calculation Register” (Annexure-2).
5.3 Verification and Reconciliation
- Shift supervisor must verify entries and calculations at the end of each shift.
- QA department shall:
- Cross-check for discrepancies
- Review monthly yield summaries
- Investigate and document variations below defined thresholds (e.g., 85%)
5.4 Trending and Reporting
- Maintain monthly and quarterly trend charts for recovery yields (Annexure-3).
- Present reports during batch review and GMP self-inspections.
- Submit yield data to Production and QA Heads for review and improvement initiatives.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- ID: Identification
7. Documents
- Solvent Recovery Log (Annexure-1)
- Yield Calculation Register (Annexure-2)
- Monthly Yield Trend Summary (Annexure-3)
8. References
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – Subpart J (Records and Reports)
- WHO GMP Guide – Documentation Practices
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 Log
| Date | Batch No. | Solvent | Volume Used (L) | Recovered (L) | Operator |
|---|---|---|---|---|---|
| 13/04/2025 | API-202504 | Acetone | 100 | 89 | R. Kumar |
Annexure-2: Yield Calculation Register
| Batch No. | Solvent | Used (L) | Recovered (L) | Yield (%) | Verified By |
|---|---|---|---|---|---|
| API-202504 | Acetone | 100 | 89 | 89.0 | QA |
Annexure-3: Monthly Yield Trend Summary
| Month | Solvent | Avg. Yield (%) | No. of Batches | Remarks |
|---|---|---|---|---|
| April 2025 | Acetone | 89.2 | 5 | Within target |
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 Summary and QA Verification | Regulatory Compliance | QA Head |