Standard Operating Procedure for Handling of Hazardous Waste

Purpose

The purpose of this SOP is to establish procedures for the safe and compliant handling, storage, and disposal of hazardous waste generated within the pharmaceutical distribution facility, ensuring protection of personnel, the environment, and regulatory compliance.

Scope

This SOP applies to all personnel involved in the generation, handling, and disposal of hazardous waste, including warehouse staff, maintenance technicians, and environmental health and safety personnel, within the distribution facility.

Responsibilities

The Environmental Health and Safety Manager is responsible for overseeing hazardous waste management activities, ensuring compliance with regulatory requirements, and providing training and guidance to personnel.
The Warehouse Supervisor is responsible for identifying and segregating hazardous waste streams, implementing appropriate storage and handling practices, and coordinating waste disposal activities with authorized vendors.
All personnel involved in hazardous waste handling are responsible for following procedures outlined in this SOP and adhering to safety protocols to prevent exposure to hazardous materials and minimize environmental impact.

Procedure

Waste Identification and Segregation:
- Identify and segregate hazardous waste streams generated within the distribution facility, including expired or damaged pharmaceutical products, chemical reagents, contaminated materials, and packaging waste.
- Use appropriate labeling and color-coding to distinguish hazardous waste containers from non-hazardous waste, and separate incompatible waste streams to prevent chemical reactions

or contamination.

Containerization and Storage:

Use designated hazardous waste containers, such as drums, bins, or containers with secondary containment, for the storage and accumulation of hazardous waste, ensuring compatibility with waste characteristics and regulatory requirements.
Store hazardous waste containers in designated storage areas with appropriate signage, ventilation, and spill containment measures to minimize risks of spills, leaks, or exposure to personnel and the environment.

Documentation and Record keeping:

Maintain accurate records of hazardous waste generation, accumulation, and disposal activities, including waste manifests, tracking logs, disposal certificates, and regulatory notifications, in accordance with regulatory requirements.
Document waste characterization data, including waste codes, quantities, and hazard classifications, to facilitate proper handling, transportation, and disposal of hazardous waste streams.

Waste Minimization and Reduction:

Implement waste minimization strategies and pollution prevention practices to reduce the generation of hazardous waste within the distribution facility, such as inventory management, process optimization, and recycling initiatives.
Identify opportunities for waste reduction, reuse, or recycling of materials to minimize environmental impact and conserve resources, and implement appropriate measures to support waste reduction goals.

Disposal and Treatment:

Contract with authorized waste disposal vendors or treatment facilities to arrange for the safe and compliant disposal or treatment of hazardous waste streams generated within the distribution facility, ensuring compliance with applicable regulations and permits.
Coordinate waste transportation, collection, and disposal activities with authorized vendors, providing accurate waste profiles, manifests, and labeling to facilitate proper handling and disposal of hazardous waste.

Abbreviations

SOP – Standard Operating Procedure

Documents

Reference documents related to handling of hazardous waste may include:

Hazardous waste management plan
Waste characterization and labeling procedures
Waste manifest forms
Disposal certificates
Regulatory guidelines on hazardous waste management

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0