Closing the Cold-Chain Gap: A Data Governance & CAPA Playbook for Pharmacy FEFO Compliance and Excursion Response
Abstract
Cold chain management for pharmaceuticals will have an extremely important role in ensuring product protection, regulatory compliance, and cost-effectiveness. The present paper provides a data governance and CAPA playbook to identify and close compliance gaps in First Expired, First Out (FEFO) operations and excursion response. Based on GDP/GxP guidance, peer-reviewed scientific publications, and industry excursion case studies, the framework includes four tiers: governance, excursion management, KPI control, and training. The playbook standardizes excursion documentation and root-cause templates, as well as a suite of KPIs, including MAPE demand forecasting, excursions per 1,000 shipments, and expiry-at-risk percentages, integrated into digital dashboards with predictive alerts for excursions. The results emphasize less spoilage with better compliance traceability and quantifiable cost savings, as well as scalability among providers and wholesalers. Moreover, the research is in line with ESG priorities of reducing waste and transparency. The research findings provide regulators, pharmacies, and logistics providers with a realistic roadmap, and future studies should investigate the integration of the IoT and advanced AI into predictive cold chain resiliency.
Citations
IRE Journals:
Omega Muchabaiwa, Munashe Naphtali Mupa, Rudorwashe Tsitsi Karuma "Closing the Cold-Chain Gap: A Data Governance & CAPA Playbook for Pharmacy FEFO Compliance and Excursion Response" Iconic Research And Engineering Journals Volume 9 Issue 3 2025 Page 802-812
IEEE:
Omega Muchabaiwa, Munashe Naphtali Mupa, Rudorwashe Tsitsi Karuma
"Closing the Cold-Chain Gap: A Data Governance & CAPA Playbook for Pharmacy FEFO Compliance and Excursion Response" Iconic Research And Engineering Journals, 9(3)
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