Even though this article only highlights the findings from a recent PWC and Axendia study looking at the future of the pharmaceutical supply chain, it echoes a number of the things I’ve heard from industry procurement and operations executives quietly expressing concern over the impact of the global sourcing of active pharmaceutical ingredients on drug safety. According to above-linked synopsis that summarizes the findings, we’re marching down a global sourcing and manufacturing path that few think we’ll back away from. To be specific, of the 112 executives interviewed for the study, “78 percent think sourcing ingredients outside the US will increase and 76 percent believing more manufacturing will be done elsewhere.”
Yet the concern over the efficacy of the extended supply chain and raw material safety is just as real today as it was before early scandals in the industry, such as tainted ingredients in Heparin sourced from China that caused a number of deaths and hospitalizations. Fundamental to this challenge is that “the standard method of supply chain monitoring though supplier audits only provides ‘snapshots in time’ [which] become increasingly expensive and complex when multiple parties are involved.” To this, I would also add based on our own discussions with different pharmaceutical executives numerous other challenges including: global suppliers consistent hitting of the low end of tolerances, logistics/handling of active pharmaceutical ingredients and API-level traceability (vs. supplier or site traceability)…
