SOP for Handling of Hazardous Waste

1) Purpose

To establish procedures for the safe handling, storage, and disposal of hazardous waste generated during pharmaceutical manufacturing processes.

2) Scope

This SOP applies to all personnel involved in the generation, handling, and disposal of hazardous waste within the pharmaceutical manufacturing facility.

3) Responsibilities

Environmental Health and Safety (EHS) Team: Responsible for overseeing hazardous waste management procedures and ensuring compliance with regulatory requirements.
Manufacturing Personnel: Responsible for segregating and labeling hazardous waste according to established procedures.
Facility Management: Responsible for providing necessary resources and ensuring infrastructure for safe waste handling.
Waste Disposal Contractors: Responsible for transporting and disposing of hazardous waste in accordance with legal and environmental regulations.

4) Procedure

1. Waste Identification and Segregation:
   1. Identify and categorize hazardous waste streams generated from manufacturing processes.
   2. Segregate waste according to its compatibility and characteristics.
   3. Label containers with appropriate hazard symbols, waste codes, and handling instructions.
2. Accumulation and Storage:
   1. Use designated storage areas for accumulating hazardous waste.
   2. Ensure containers are compatible with waste contents and are kept closed when not in use.
   3. Monitor waste accumulation to prevent overfilling and leakage.
3. Transportation and Disposal:
   1. Contract with authorized waste disposal contractors for transportation.
   2. Prepare waste for transportation by securing containers and completing required documentation.
   3. Ensure waste disposal is conducted by licensed facilities in compliance with regulatory standards.
4. Training and Emergency Response:
   1. Provide training to personnel on hazardous waste handling procedures and emergency response protocols.
   2. Maintain emergency response equipment and procedures for spills or incidents involving hazardous waste.
   3. Regularly conduct drills to ensure readiness for waste-related emergencies.

5) Abbreviations, if any

SOP – Standard Operating Procedure

EHS – Environmental Health and Safety

6) Documents, if any

• Hazardous Waste Manifests
• Training Records
• Waste Disposal Contracts
• Emergency Response Plans

7) Reference, if any

EPA Regulations for Hazardous Waste Management

8) SOP Version

Version 1.0