Procurement of Hazardous Materials – Standard Operating Procedure

1) Purpose

To establish guidelines for the procurement of hazardous materials, ensuring safe handling, compliance with regulations, and proper documentation within the pharmaceutical purchase department.

2) Scope

This SOP applies to all procurement activities involving hazardous materials, including order placement, receipt, storage, and documentation.

3) Responsibilities

Procurement Manager: Responsible for overseeing the procurement process and ensuring compliance with safety and regulatory standards.
Procurement Team: Responsible for executing procurement activities and maintaining accurate records of hazardous materials.
Safety Officer: Responsible for ensuring safe handling and storage of hazardous materials and providing relevant training.

4) Procedure

4.1) Supplier Qualification:
4.1.1) Select suppliers authorized to handle and distribute hazardous materials.
4.1.2) Verify supplier compliance with relevant regulatory requirements and safety standards.

4.2) Order Placement:
4.2.1) Ensure purchase orders for hazardous materials are placed with approved suppliers.
4.2.2) Include necessary documentation and authorization with each order, as required by regulations.

4.3) Receipt of Hazardous Materials:
4.3.1) Verify the accuracy of delivered hazardous materials against the purchase order and accompanying documentation.
4.3.2) Record the receipt in a hazardous materials log, including quantities, batch numbers, and storage locations.
4.3.3) Inspect packaging for any damage or leaks and take appropriate action if issues are found.

4.4) Storage and Security:
4.4.1) Store hazardous materials in designated, secure areas with appropriate signage.
4.4.2) Implement safety measures such as secondary containment, ventilation, and spill control equipment.
4.4.3) Ensure that access to storage areas is restricted to authorized personnel only.

4.5) Safety and Handling:
4.5.1) Provide training for personnel on the safe handling and use of hazardous materials.
4.5.2) Ensure that appropriate personal protective equipment (PPE) is available and used when handling hazardous materials.
4.5.3) Develop and implement emergency procedures for spills, exposure, and other incidents.

4.6) Documentation and Record Keeping:
4.6.1) Maintain detailed records of all transactions involving hazardous materials, including orders, receipts, and usage.
4.6.2) Ensure records are complete, accurate, and readily available for regulatory inspections.

4.7) Compliance and Audits:
4.7.1) Conduct regular audits to verify compliance with regulatory requirements and internal procedures.
4.7.2) Address any discrepancies or non-compliance issues promptly and implement corrective actions.

4.8) Disposal of Hazardous Materials:
4.8.1) Follow regulatory guidelines for the disposal of expired, unused, or excess hazardous materials.
4.8.2) Document the disposal process, including quantities and methods used, in accordance with regulatory requirements.

5) Abbreviations, if any

• PPE: Personal Protective Equipment

6) Documents, if any

• Purchase Orders
• Hazardous Materials Log
• Supplier Compliance Certificates
• Audit Reports
• Safety Data Sheets (SDS)
• Disposal Records

7) Reference, if any

Regulatory Guidelines: OSHA Hazard Communication Standard, EPA regulations
Industry Standards: ISO 45001:2018

8) SOP Version

Version 1.0