Blockchain-Enabled Traceability in Pharmaceutical Supply Chains: An Integrated Engineering and It Management Framework for Regulatory Compliance and Pandemic Resilience

Abstract

Due to the growing risk of counterfeit medicines, the highly disjointed international regulatory landscape, and the strong desire to learn more about where the medicines are supplied in health emergencies like the COVID-19 pandemic, pharmaceutical supply chains are experiencing mounting pressure to guarantee transparency, authenticity, and compliance. These complexities were used to show the necessity to have robust, secure, and interoperable systems that can facilitate real-time traceability at all levels of the pharmaceutical value chain. Blockchain technology has emerged as a revolutionary remedy that can integrate such problems since it provides unalterable records, decentralized data management, and automated smart contracts. Nevertheless, knowing how to introduce it into the spheres of the pharmaceutical world demands a multi-disciplinary approach to planning that closes the gap between engineering processes and IT management procedures. This paper suggests a new combined engineering and IT governance system that uses blockchain powered traceability to achieve regulatory compliance and be resilient to the pandemic. The framework involves end-to-end coverage of manufacturing all the way to point-of-care, including the physical traceability through IoT-based tracking and blockchain design, compliance-oriented data layers, and the capability of smart contracts. The framework also allows agile incident response to supply chain interruptions, increased recall speed, and proactive measures when dealing with counterfeits, since the digital infrastructure will be aligned with major regulatory requirements, such as the U.S. Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive (FMD). Besides conceptualized design, there are well-organized tables explaining regulatory mappings, framework components, and performance measures in this article. The framework presents a crossdisciplinary and scalable concept of modernization of the pharmaceutical supply chain, which is expected to facilitate the process of digitalization to align with the goals of Pharma 4.0 and the security of public health in the post-pandemic world.