PDA publishes Technical Report on Last Mile Distribution

The Parenteral Drug Association (PDA) has published a new document entitled "PDA Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users."

This revised version of TR 46, published in August 2024, provides details on temperature control, monitoring and security, and data management, with a focus on supply chain management. Furthermore, the document covers supply chains in Europe, Africa, Brazil, U.S., Canada and China.

On its website, the PDA notes that the document "complements the information provided in Technical Report No. 39 (Revised 2021): Guidance for Temperature-Controlled Medicinal Products — Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment by going beyond manufacturer-focused issues and addressing issues specifically encountered within the last mile of the distribution of medicinal products and devices. This revision updates the original 2009 technical report to account for expanded regulations, the development and implementation of newer, more advanced technologies and supply chains that have become more extensive and complex."

Table of Contents

The document's table of contents includes:

• Introduction
• Glossary and Abbreviations
• Pharmaceutical Supply Chains
• Pharmaceutical Products
• Services and Temperature Controlled Systems
• Data and Knowledge Management
• Cost Management and Sustainability
• Summary
• References

For further details on the document and to download it as a PDA members, or to make a purchase, please visit the PDA website.