Standard Operating Procedure for Disposal of Non-Recoverable Solvents in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/049/2025 |
| Supersedes | SOP/API/049/2022 |
| 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 safe, traceable, and environmentally compliant disposal of non-recoverable solvents generated during API manufacturing, in accordance with GMP, CPCB, and EHS guidelines.
2. Scope
This SOP applies to all solvent waste that is non-recoverable due to contamination, degradation, or process suitability and requires disposal from the API manufacturing site.
3. Responsibilities
- Production Department: Identify and label non-recoverable solvents.
- EHS Department: Arrange for safe transport and disposal through authorized vendors.
- QA Department: Review and verify documentation related to disposal.
4. Accountability
The EHS Manager is accountable for ensuring safe and compliant disposal of non-recoverable solvents. QA is responsible for verifying records and traceability.
5. Procedure
5.1 Identification of Non-Recoverable Solvents
- Classify solvents as non-recoverable if:
- They fail purity specifications post-recovery
- They are mixed with incompatible or unidentified residues
- Contain toxic or hazardous degradation products
- Label each container with:
- “Non-Recoverable Solvent”
- Solvent name
- Volume and batch details
- Disposal authorization number
- Record in the “Non-Recoverable Solvent Log” (Annexure-1).
5.2 Temporary Storage
- Store labeled containers in a dedicated “Hazardous Waste Storage Area.”
- Ensure:
- Leak-proof containment with spill trays
- Fire extinguisher access
- Separate incompatible solvents (e.g., chlorinated vs. non-chlorinated)
- Mark containers with “Awaiting Disposal” tags.
5.3 Disposal Process
- Coordinate with CPCB/SPCB approved waste management vendors.
- Generate manifest with:
- Consignment number
- Solvent type and quantity
- Date and location of pickup
- Obtain signed acknowledgment and manifest from the transporter and disposal facility.
- Attach manifest copy to the “Disposal Authorization Record” (Annexure-2).
5.4 Documentation and Audit
- Maintain disposal records for minimum of five years or as per local regulations.
- Ensure reconciliation of generated vs. disposed solvent volumes quarterly.
- Submit disposal summaries to the EHS Committee monthly.
- Make all disposal records available during internal and regulatory inspections.
6. Abbreviations
- SOP: Standard Operating Procedure
- CPCB: Central Pollution Control Board
- SPCB: State Pollution Control Board
- EHS: Environment, Health and Safety
- QA: Quality Assurance
7. Documents
- Non-Recoverable Solvent Log (Annexure-1)
- Disposal Authorization Record (Annexure-2)
- Waste Manifest Copy (Annexure-3)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- CPCB Guidelines for Hazardous Waste Management (2016)
- Factories Act, 1948 – Environmental Provisions
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Non-Recoverable Solvent Log
| Date | Solvent | Batch No. | Qty (L) | Reason | Label ID |
|---|---|---|---|---|---|
| 13/04/2025 | Methanol | RCV-2025-010 | 55 | Failed QC | NR-025 |
Annexure-2: Disposal Authorization Record
| Date | Vendor | Qty Disposed (L) | Manifest No. | Authorized By |
|---|---|---|---|---|
| 14/04/2025 | EcoSafe Disposals | 55 | ESD-1254 |
Annexure-3: Waste Manifest Copy
Attach scanned image or photocopy of signed manifest received from CPCB/SPCB authorized vendor.
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | New Hazardous Waste Policy | QA Head |
| 13/04/2025 | 2.0 | Updated Documentation Format & CPCB Integration | Regulatory Alignment | QA Head |