Contributing to the Improvement of Cold Chain Risk Management in Pharmaceutical Distribution Case Study: Central Pharmacy of Hospitals, Annaba

Abstract

In the Algerian public pharmaceutical distribution sector, managing the cold chain is essential to ensure drug integrity and patient safety. This study explores this challenge at the Annaba Annex of the Central Pharmacy of Hospitals (PCH), a facility facing infrastructural constraints, high inbound stock volumes, and dependencies on long-distance transportation.The research aims to identify cold chain vulnerabilities and propose a transition from reactive crisis management to proactive Quality Risk Management.This study adopts a qualitative approach based on semi-structured interviews analyzed through thematic analysis using NVivo. To support the evaluation and prioritization of identified risks, the qualitative findings were complemented by risk assessment tools, namely the Ishikawa diagram and the Failure Mode and Effects Analysis (FMEA) matrix.The findings highlight major logistical risks within a highly constrained physical environment. Externally, the facility suffers from a thermal traceability “blind spot” during upstream transportation. Internally, severe spatial congestion and frequent cold-room door openings compromise temperature stability.Furthermore, the facility’s risk governance lacks maturity: the ISO 9001:2015 certification has not been renewed, formal Standard Operating Procedures (SOPs) are absent, and monitoring remains strictly reactive.Ultimately, these root causes underscore the urgent need for a structured Corrective and Preventive Action (CAPA) plan to sustainably strengthen cold-chain resilience