Abstract

The pharmaceutical supply chain in the US demonstrates a link to quality objectives of organizations; predicated on implications for regulatory compliance, patient safety, and operational excellence. This paper examines the ways in which the US pharmaceutical supply chain informs quality objectives, alongside described challenges. The literature was informed by regulatory frameworks, policy literature, and publications from industry organizations, with a few cases studies. Findings indicate contributions to quality objectives are largely achieved through robust quality management systems, uptake of technologies to improve quality, and collaboration across stakeholders. However, the sector is beset by significant challenges including global sourcing risks, regulatory considerations, cold chain risks, and drug shortages. Multi-national corporations such as Pfizer, Johnson and Johnson, and Merck have highlighted resilience and innovation will be achieved by accessing digital tools for quality assurance, diversifying sourcing, and investing in the advancement of quality systems. Some strategies to address challenges include FDA driven quality metrics, the application of advanced technologies, decentralized sourcing, and solidifying partnerships. US-specific opportunities highlight the demand for ongoing investment in manufacturing capacity, supply chain resiliency, and regulatory modernization.