With a maze of regulations across global jurisdictions and even more complex, temperature-sensitive pharmaceutical and healthcare product requirements, the life sciences supply chain is under pressure to adapt. And from the EU’s Good Distribution Practice guidelines to Brazil’s stringent serialization laws, regulatory compliance is only increasing. In the U.S., serialization, the next phase of the Drug Supply Chain Security Act (DSCSA), goes into effect next year for pharmaceutical manufacturers. By 2023, the Act will ensure that manufacturers, repackagers, distributors and dispensers can only transact with serialized product, ensuring unit level traceability across the pharma supply chain. How are supply chain leaders in the pharmaceutical and healthcare industries coping?
Topics: digital supply chain, DSI cloud inventory™, healthcare, life sciences supply chain, mobile-first supply chain, pharma supply chain, pharma supply chain management, pharmaceuticals, serialization, Solutions, Supply Chain Management, supply chain solutions
According to a recent supplement of the American Journal of Tropical Medicine and Hygiene, between 9 and 41 percent of medications in a sample of 16,800 drugs fell short of meeting quality standards. In an industry whose offerings include lifesaving drugs, substandard products put the public health at risk—and the stakes couldn’t be higher. In a foreword to the supplement, former FDA Commissioner Margaret Hamburg writes, “Substandard and falsified medical products pose significant risks to global health with potentially devastating and far-reaching consequences.” The crux of the problem is a lack of visibility along the supply chain, which can lead to these vulnerabilities.