Standard Operating Procedure for Handling of Hazardous Materials

Purpose

The purpose of this SOP is to establish procedures for the safe handling, storage, and disposal of hazardous materials within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and minimizing risks to personnel, products, and the environment.

Scope

This SOP applies to all personnel involved in the handling of hazardous materials within the distribution facility, including receiving, storage, use, and disposal.

Responsibilities

• The Hazardous Materials Coordinator is responsible for overseeing the safe handling and management of hazardous materials within the facility.
• All personnel are responsible for adhering to procedures outlined in this SOP and receiving appropriate training on the safe handling of hazardous materials.
• The Facilities Management Team is responsible for ensuring that storage areas and facilities for hazardous materials meet regulatory requirements and are equipped with necessary safety features.

Procedure

1. Identification of Hazardous Materials:
   • Identify and classify hazardous materials present within the facility based on their physical, chemical, and toxicological properties.
   • Label hazardous materials containers with appropriate hazard symbols, warning labels, and safety information according to regulatory requirements.
2. Storage and Handling:
   • Store hazardous materials in designated areas with adequate ventilation, containment, and segregation from incompatible substances.
   • Handle hazardous materials with appropriate personal protective equipment (PPE) and follow established procedures to minimize exposure risks.
3. Spill Response:
   • Develop spill response procedures outlining steps to be taken in the event of a spill or release of hazardous materials.
   • Provide spill response kits and containment materials in areas where hazardous materials are used or stored.
   • Train personnel on spill response procedures and the proper use of spill containment equipment.
4. Disposal:
   • Segregate and package hazardous waste materials for disposal according to regulatory requirements and waste management protocols.
   • Label hazardous waste containers with appropriate waste codes, disposal instructions, and safety information.
   • Arrange for the proper disposal of hazardous waste through licensed waste disposal contractors or facilities.
5. Training and Documentation:
   • Provide initial and ongoing training to personnel involved in the handling of hazardous materials, covering safety procedures, PPE usage, and emergency response.
   • Maintain records of hazardous materials inventory, usage, disposal, and training to demonstrate compliance with regulatory requirements.

Abbreviations

• SOP – Standard Operating Procedure
• PPE – Personal Protective Equipment

Documents

Reference documents related to handling of hazardous materials may include:

• Hazardous materials inventory
• Safety data sheets (SDS)
• Spill response procedures
• Waste disposal manifests
• Training records

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0