Standard Operating Procedure for Testing of Recovered Solvents for Reuse in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/043/2025 |
| Supersedes | SOP/API/043/2022 |
| 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 quality control testing of recovered solvents to ensure they conform to defined specifications and are suitable for reuse in API manufacturing processes, in compliance with GMP and regulatory standards.
2. Scope
This SOP applies to all recovered solvents intended for reuse after in-house distillation or third-party purification. It covers testing, documentation, approval, and storage for GMP-compliant operations.
3. Responsibilities
- QC Analyst: Perform testing as per approved specifications and record results.
- QA Officer: Review results and approve or reject recovered solvent usage.
- Production Team: Label and store recovered solvents pending test results.
4. Accountability
The QC Head is accountable for releasing or rejecting recovered solvents based on test results. The QA Head ensures compliance with SOP and regulatory acceptance.
5. Procedure
5.1 Sampling of Recovered Solvent
- Collect samples from each recovered solvent batch in a clean, dry, amber-colored bottle.
- Label sample bottles with:
- Solvent name
- Batch number
- Date of recovery
- Sample ID
- Record sampling details in the “Recovered Solvent Sampling Log” (Annexure-1).
5.2 Analytical Testing Parameters
- Test parameters shall include:
- Appearance (color, clarity, odor)
- Purity (by GC or suitable method)
- Boiling point range (to detect impurities)
- Specific gravity (if applicable)
- Water content (Karl Fischer)
- Residue on evaporation (non-volatile matter)
- pH of aqueous extract (if applicable)
- Use validated methods as per in-house or pharmacopeial standards.
- Record results in “Recovered Solvent QC Report” (Annexure-2).
5.3 Acceptance Criteria
- Compare results with approved solvent specification limits.
- Solvents not meeting one or more specifications must be rejected or reprocessed.
- Record final decision in the “Recovered Solvent Approval Log” (Annexure-3).
5.4 Labeling and Storage Post Testing
- Approved solvents shall be labeled as “Approved for Reuse.”
- Rejected solvents shall be labeled “Rejected – Not for Reuse” and segregated for disposal.
- Store approved solvents in a designated solvent area with proper identification tags.
6. Abbreviations
- SOP: Standard Operating Procedure
- QC: Quality Control
- QA: Quality Assurance
- GC: Gas Chromatography
- KF: Karl Fischer
7. Documents
- Recovered Solvent Sampling Log (Annexure-1)
- Recovered Solvent QC Report (Annexure-2)
- Recovered Solvent Approval Log (Annexure-3)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – Subpart I & J
- USP/EP Specifications for Solvents
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Recovered Solvent Sampling Log
| Date | Solvent Name | Batch No. | Sample ID | Collected By |
|---|---|---|---|---|
| 13/04/2025 | Methanol | RCV-202504 | SOL-101 |
Annexure-2: Recovered Solvent QC Report
| Test | Result | Specification | Status |
|---|---|---|---|
| Purity | 99.7% | ≥99.5% | Pass |
| Boiling Point | 64.5°C | 64.0–65.5°C | Pass |
Annexure-3: Recovered Solvent Approval Log
| Date | Solvent | Batch No. | Result | Approved/Rejected | QA Sign |
|---|---|---|---|---|---|
| 13/04/2025 | Methanol | RCV-202504 | Complies | Approved |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | New Testing Requirement | QA Head |
| 13/04/2025 | 2.0 | Enhanced parameters, added Annexures | GMP Compliance | QA Head |