Technical Report No. 46 (Revised 2024) Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users

PDA Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users 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.　

Last mile distribution is an often-used logistical term that refers to the transport of products from the manufacturing facility to the end user. For the purposes of this technical report, last mile is defined as the final transfer of a drug from the manufacturer or wholesaler to the end user which could be either the patient or the entity (e.g., pharmacy, hospital) that provides the drug to the patient.　　

Transfers earlier in the distribution process involve organizations with greater knowledge of the product and the resources to ensure carefully controlled conditions of storage and transport compared to those available to the end user. As such, PDA Technical Report No. 46 provides recommendations and tools based on current best practices to ensure that product quality is maintained in the last mile, including guidance on temperature control, monitoring and security, and data management, with a focus on supply chain management. Additionally, it covers supply chains in Europe, Africa, Brazil, U.S., Canada and China.