Standard Operating Procedure for Segregation and Disposal of Hazardous Waste in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/203/2025 |
| Supersedes | SOP/API/203/2022 |
| Page No. | Page 1 of 14 |
| Issue Date | 14/04/2025 |
| Effective Date | 16/04/2025 |
| Review Date | 14/04/2026 |
1. Purpose
To define the procedures for the identification, segregation, labeling, temporary storage, transportation, and disposal of hazardous waste generated in API manufacturing operations in accordance with GMP, CPCB, and environmental safety guidelines.
2. Scope
This SOP applies to all departments within the API manufacturing facility involved in the handling of hazardous waste, including solvents, contaminated materials,
expired chemicals, and rejected intermediates. It includes both production and warehouse areas.
3. Responsibilities
- Production & Warehouse Personnel: Identify and segregate hazardous waste at source.
- EHS Department: Manage waste labeling, documentation, temporary storage, and disposal.
- QA Department: Ensure compliance with SOP and maintain oversight of waste handling records.
- Approved Vendors: Transport and dispose hazardous waste as per legal requirements.
4. Accountability
The Head of EHS is accountable for ensuring hazardous waste disposal complies with statutory regulations, and that internal handling meets GMP and site safety standards.
5. Procedure
5.1 Identification of Hazardous Waste
- Types of hazardous waste generated:
- Spent solvents and solvent mixtures
- Contaminated PPE or spill absorbents
- Expired or off-spec chemicals
- Rejected batches or intermediates
- Used lab reagents and glassware
- Material Safety Data Sheets (SDS) must be consulted to confirm hazard classification.
5.2 Segregation Guidelines
- Segregate waste at point of generation using:
- Red containers – Flammable/Organic solvent waste
- Yellow containers – Reactive or corrosive chemicals
- Black bags – Contaminated solid waste (e.g., gloves, wipes)
- Ensure incompatible substances are not mixed (e.g., acids with bases).
- Place spill-proof labels on all containers (see Annexure-1).
5.3 Labeling and Documentation
- Each hazardous waste container must have:
- Waste description
- Date of generation
- Hazard classification
- Department and responsible person
- Use the Hazardous Waste Tag format provided in Annexure-1.
- Record entries in the Hazardous Waste Register (Annexure-2).
5.4 Temporary Storage
- Transfer containers to the Hazardous Waste Storage Room once 75% full or within 7 days.
- Storage area must:
- Be well-ventilated
- Have spill containment pallets
- Be secured and access-controlled
- Post appropriate hazard signage (see Annexure-3).
5.5 Disposal Process
- Disposal is permitted only via authorized and licensed vendors (listed in Annexure-4).
- Vendor shall:
- Provide manifest form as per Hazardous Waste Management Rules
- Transport waste in DG-compliant containers
- Maintain copies of disposal records and manifest in the Hazardous Waste Disposal File.
5.6 Handling Precautions
- Personnel handling waste must wear:
- Nitrile gloves
- Face shield
- Coverall or lab coat
- Do not open filled containers without EHS authorization.
- Emergency eyewash and shower stations must be nearby.
5.7 Spill and Incident Management
- Follow SOP/API/202/2025 for managing hazardous waste spills.
- Report incidents using the Hazardous Waste Incident Report Form (Annexure-5).
5.8 Training and Audit
- Quarterly training to be conducted for relevant staff.
- EHS shall audit segregation and storage areas monthly using the Hazardous Waste Audit Checklist (Annexure-6).
6. Abbreviations
- SOP: Standard Operating Procedure
- SDS: Safety Data Sheet
- EHS: Environment, Health & Safety
- DG: Dangerous Goods
- CAPA: Corrective and Preventive Action
7. Documents
- Hazardous Waste Label – Annexure-1
- Hazardous Waste Register – Annexure-2
- Hazardous Storage Signage – Annexure-3
- Authorized Vendor List – Annexure-4
- Hazardous Waste Incident Report Form – Annexure-5
- Hazardous Waste Audit Checklist – Annexure-6
8. References
- Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 – CPCB
- GMP Guidelines – WHO, ICH Q9
- EPA Guidelines for Chemical Waste Handling
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Hazardous Waste Label Format
| Field | Example Entry |
|---|---|
| Waste Description | Spent Acetone |
| Hazard Class | Flammable |
| Department | API Production |
| Date of Generation | 13/04/2025 |
Annexure-2: Hazardous Waste Register
| Date | Waste Type | Quantity | Location | Disposed By |
|---|---|---|---|---|
| 13/04/2025 | Acetone | 25 L | Solvent Room | Sunita Reddy |
Annexure-3: Hazardous Storage Area Signage
Label: “DANGER – HAZARDOUS WASTE STORAGE AREA – AUTHORIZED PERSONNEL ONLY”
Font: Bold, red text on white background (A2 size)
Annexure-4: Authorized Vendor List
| Vendor Name | Approval No. | Contact | Region |
|---|---|---|---|
| EcoSafe Disposals Pvt. Ltd. | CPCB/2025/014 | +91-9876543210 | Maharashtra |
Annexure-5: Hazardous Waste Incident Report Form
| Date | Location | Waste Type | Cause | Corrective Action |
|---|---|---|---|---|
| 12/04/2025 | Warehouse | Acid Drum Leak | Damaged Cap | Replaced container & updated SOP |
Annexure-6: Hazardous Waste Audit Checklist
| Checkpoint | Compliant (Yes/No) | Remarks |
|---|---|---|
| Labeling Complete | Yes | All containers labeled |
| Storage Area Locked | No | Lock missing |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Issue | New SOP | QA Head |
| 14/04/2025 | 2.0 | Annexures, vendor list, and audit checklist added | GMP and CPCB Compliance | QA Head |