Standard Operating Procedure for Transportation Management

Purpose

The purpose of this SOP is to establish procedures for the safe, efficient, and compliant transportation of pharmaceutical products, in accordance with Good Distribution Practice (GDP) guidelines.

Scope

This SOP applies to all personnel involved in the planning, execution, and monitoring of transportation activities for pharmaceutical products.

Responsibilities

• The Logistics Department is responsible for coordinating transportation arrangements and ensuring compliance with regulatory requirements.
• The Quality Assurance (QA) Department is responsible for assessing transportation risks and monitoring compliance with GDP guidelines.
• The Distribution Department is responsible for preparing products for shipment and ensuring proper packaging and labeling.
• The Transportation Service Provider is responsible for transporting pharmaceutical products safely and securely.

Procedure

1. Transportation Planning:
   • Identify transportation requirements based on product characteristics, destination, and regulatory requirements.
   • Select appropriate transportation modes and service providers based on safety, reliability, and cost-effectiveness.
2. Preparation of Shipment:
   • Ensure proper packaging of pharmaceutical products to protect against environmental factors, shock, and vibration during transit.
   • Label shipments with appropriate information, including product name, quantity, handling instructions, and temperature requirements.
3. Temperature Control:
   • Monitor and record temperature conditions during transportation to ensure compliance with specified storage requirements.
   • Use validated temperature-controlled containers or vehicles for products requiring temperature maintenance.
4. Documentation and Records:
   • Maintain accurate records of transportation activities, including shipment details, temperature logs, and any deviations or