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 incidents.
   • Ensure all required transportation documents, such as bills of lading and shipping manifests, are completed and retained as per regulatory requirements.
5. Monitoring and Compliance:
   • Monitor transportation performance against predefined key performance indicators (KPIs) to ensure compliance with service level agreements and GDP guidelines.
   • Conduct periodic audits or inspections of transportation processes and service providers to verify compliance.
6. Incident Management:
   • Establish procedures for responding to transportation incidents, such as accidents, delays, or temperature excursions.
   • Investigate root causes of incidents and implement corrective actions to prevent recurrence.

Abbreviations

• QA – Quality Assurance
• GDP – Good Distribution Practice
• KPIs – Key Performance Indicators

Documents

Reference documents related to transportation management may include:

• Transportation agreements and contracts
• Shipping instructions and packaging guidelines
• Temperature monitoring records
• Transportation incident reports
• Regulatory requirements for transportation of pharmaceutical products

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0