Key Points from the Lecture on Good Distribution Practices (GDP)

Introduction

• Daily millions of medicinal products are transported globally.
• Importance of maintaining quality, effectiveness, and safety during transportation to help people.

Challenges in Transportation

• Risks during transportation include:
  • Too low or too high temperatures.
  • Incorrect handling.
  • Poor hygiene.
• These issues can compromise the quality of medicinal products.

European Commission Guidelines

• The European Commission has established guidelines for Good Distribution Practices (GDP).
• GDP ensures:
  • Controlled supply chain for medicinal products.
  • Prevention of counterfeit products in the market.

Maintaining Quality in Global Transportation

• A Quality Management System is essential.
• Systematic identification and assessment of transport risks.
• Appropriate methods for:
  • Storage.
  • Transportation.
  • Distribution.
  • On-time delivery.

Requirements for Warehouses and Vehicles

• Must be:
  • Clean.
  • Dry.
  • Temperature-controlled.
• Important information to be maintained include:
  • Product name.
  • Strength.
  • Batch number.
  • Expiry date.

Packaging and Personnel Training

• Proper packaging protects products from environmental factors.
• Personnel must be trained to ensure compliance with transport conditions.

Handling Unplanned Events

• Document and investigate any damage that occurs during transportation.
• Implement Corrective and Preventive Actions (CAPA) to restore quality.

Serialization and Counterfeit Prevention

• Serialization will simplify the verification of genuine products.
• Enhanced protection for patients against counterfeit products.

Responsibilities in the Supply Chain

• All parties involved have significant responsibilities, including:
  • Manufacturers.
  • Freight forwarders.
  • Carriers.
  • Wholesalers.
• Medicinal products stored incorrectly, even for a short time, can become unusable or dangerous.

Conclusion

• Following GDP guidelines can prevent issues and ensure products maintain their intended goal to help people.
• Collaboration across the supply chain is critical.

Contact Information

• For further information, personal training, or consultation, contact EQM Quality and Risk Management.