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

1. 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
2. Label each container with:
   • “Non-Recoverable Solvent”
   • Solvent name
   • Volume and batch details
   • Disposal authorization number
3. Record in the “Non-Recoverable Solvent Log” (Annexure-1).

5.2 Temporary Storage

1. Store labeled containers in a dedicated “Hazardous Waste Storage Area.”
2. Ensure:
   • Leak-proof containment with spill trays
   • Fire extinguisher access
   • Separate incompatible solvents (e.g., chlorinated vs. non-chlorinated)
3. Mark containers with “Awaiting Disposal” tags.

5.3 Disposal Process

1. Coordinate with CPCB/SPCB approved waste management vendors.
2. Generate manifest with:
   • Consignment number
   • Solvent type and quantity
   • Date and location of pickup
3. Obtain signed acknowledgment and manifest from the transporter and disposal facility.
4. Attach manifest copy to the “Disposal Authorization Record” (Annexure-2).

5.4 Documentation and Audit

1. Maintain disposal records for minimum of five years or as per local regulations.
2. Ensure reconciliation of generated vs. disposed solvent volumes quarterly.
3. Submit disposal summaries to the EHS Committee monthly.
4. 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

1. Non-Recoverable Solvent Log (Annexure-1)
2. Disposal Authorization Record (Annexure-2)
3. 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