Standard Operating Procedure for Storage Conditions for Recovered Solvents in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/045/2025 |
| Supersedes | SOP/API/045/2022 |
| 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 required storage conditions for recovered solvents in API manufacturing, ensuring their stability, safety, traceability, and readiness for reuse while maintaining compliance with GMP and environmental regulations.
2. Scope
This SOP applies to all recovered solvents that have been tested and labeled after distillation or purification within the API manufacturing facility and are stored for future reuse or disposal.
3. Responsibilities
- Warehouse Personnel: Store and monitor recovered solvent containers as per SOP.
- QA Department: Verify proper labeling and storage compliance.
- EHS Team: Monitor environmental and safety requirements of solvent storage area.
4. Accountability
The Warehouse Manager is accountable for maintaining proper storage conditions. The QA Head is responsible for documentation verification and traceability.
5. Procedure
5.1 Storage Area Requirements
- Recovered solvents must be stored in a designated, segregated area marked as “Recovered Solvent Storage.”
- The area must be:
- Well-ventilated
- Away from direct sunlight and heat sources
- Equipped with fire protection measures (foam extinguisher, sand bucket)
- Covered by a roof with proper drainage
- Secondary containment trays must be in place to prevent leakage or spills from spreading.
- Proper signage for hazardous material handling must be displayed.
5.2 Container and Labeling Control
- Only labeled containers as per SOP/API/044/2025 are allowed into storage.
- Containers must be:
- Closed tightly with sealed lids
- Made of chemically compatible materials (e.g., stainless steel, HDPE)
- Stored with labels facing outward and legible
- Keep separate zones for:
- Approved for Reuse
- Rejected Solvents (pending disposal)
5.3 Environmental Monitoring and Control
- Record ambient temperature and relative humidity of the storage area daily in the “Storage Condition Monitoring Log” (Annexure-1).
- Maintain temperature between 15°C–30°C, unless solvent-specific storage conditions dictate otherwise.
- Use flameproof electrical fittings and exhaust ventilation where applicable.
- Ensure all solvents are grounded and bonded to prevent static discharge during movement.
5.4 Inventory and Movement
- Enter each drum or container into the “Recovered Solvent Storage Inventory Register” (Annexure-2).
- Log each movement (in/out of the area) and the destination (e.g., recovery, production, disposal).
- Ensure FIFO (First In, First Out) or usage based on validity is followed.
5.5 Inspection and Cleaning
- Inspect storage drums weekly for any corrosion, leakage, or label fading.
- Clean the storage area floor weekly and maintain the “Cleaning Log” (Annexure-3).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- EHS: Environment, Health, and Safety
- HDPE: High-Density Polyethylene
- FIFO: First In First Out
7. Documents
- Storage Condition Monitoring Log (Annexure-1)
- Recovered Solvent Storage Inventory Register (Annexure-2)
- Storage Area Cleaning Log (Annexure-3)
8. References
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – Subpart C (Buildings and Facilities)
- WHO TRS 957 – Annex 2 (Environmental Controls)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Storage Condition Monitoring Log
| Date | Time | Temperature (°C) | Relative Humidity (%) | Checked By | Remarks |
|---|---|---|---|---|---|
| 13/04/2025 | 09:00 | 26 | 55 | Within limits |
Annexure-2: Recovered Solvent Storage Inventory Register
| Date | Solvent | Batch No. | Qty (L) | Storage Zone | Status |
|---|---|---|---|---|---|
| 13/04/2025 | Acetone | RCV-202504 | 80 | Zone A | Approved for Reuse |
Annexure-3: Storage Area Cleaning Log
| Date | Area Cleaned | Cleaned By | Verified By | Remarks |
|---|---|---|---|---|
| 13/04/2025 | Recovered Solvent Bay | No issues |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | New Regulatory Requirement | QA Head |
| 13/04/2025 | 2.0 | Environmental Monitoring Logs Added | GMP Compliance | QA Head |