Good Distribution Practice

The goal of manufacturing pharmaceuticals and medical devices is for patients to use them and experience the therapeutic effect that they have. This purpose will be defeated in the absence of a distribution system that works. This course teaches about maintaining the supply chain integrity and ensuring that the products manufactured are transported from the point of production through warehouses and medical facilities to the patients in optimal quality. This is done by taking into account the appropriate transport and storage conditions.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

• What is Supply Chain Integrity?
• Why is Good Distribution Practice and Supply Chain Integrity Critical?
• What Are the Legislations and Guidelines That Address Supply Chain Integrity?
• Where Are GDP Guidelines Applicable?
• General Principle

Lesson 1: The Organizational Structure

• What Are the Regulatory Requirements for the Distributor or Its Organization?
• How is the Organizational Structure Managed Under GDP Guidelines?
• Aspects of Organizational Structure
• Personnel
• What Are the Responsibilities of Designated Responsible Personnel?
• Quality System
• Quality Risk Management

Lesson 2: Premises and Equipment

• The Storage Facilities
• Temperature and Environment Control
• What Is Meant by Initial Temperature Mapping?
• What Are the GDP Guidelines for Receiving and Dispatching Bays?
• The Quarantine Areas
• What is First Expiry/First Out?
• What Functions Represent the Most Risk to Supply Chain Integrity

Lesson 3: Shipment and Transportation

• Requirements for Vehicles and Equipment
• How Segregation and Security of Materials During Transit is Maintained
• What about Specialized Environmental Conditions During Transit?
• Shipment Containers and Container Labeling
• Dispatch and Receipt
• What Are the Guidelines For Outsourced Shipment Contracts?
• How to Plan the Transportation of Pharmaceutical Products?
• How to Maintain Supply Chain Integrity During Transportation?

Lesson 4: Documentation

• How Is the Distribution Record of Pharmaceutical Products Maintained?
• What Is the Standard Operation Procedure?
• What Are the Criteria for Retention of Documentation?

Lesson 5: Handling of Complaints, Recalls, Returned, and Rejected Pharmaceutical Products

• Complaints
• Recalls
• Returned Products
• Counterfeit Pharmaceutical Products

Lesson 6: Guidelines Related to Importation, Contract Activities, and Self-Inspection of the Distribution Chain

• Importation
• Contract Activities
• Self-Inspection

Conclusion

Glossary

Quiz