Qualification of the Cold Chain of Thermolabile Drugs: Proposal of a Self-Diagnosis Tool for Good Distribution Practices

Abstract

Effective management of thermolabile drugs is crucial to ensuring their quality and therapeutic efficacy. These medications, which are sensitive to temperature fluctuations, require rigorously controlled distribution processes in compliance with pharmaceutical supply chain best practices. This study proposes a methodological framework to consolidate and formalize good distribution practices for thermosensitive drugs, based on guidelines derived from European standards. Additionally, a scoring system was developed to evaluate the degree of compliance with these distribution practices across drug distribution facilities and pharmacies. The tool was successfully tested at Hassani Hospital Pharmacy in Nador, enabling comprehensive analysis and improvement of existing practices.