The “race to the bottom” for cost and the cumulative effect of “lean-out” global supply chains have had an unintended consequence for the safe, reliable supply of product.

Third-party management has become a growing and recognized risk. And then there’s fourth- and fifth-party management. They are all-important parts of supply chain challenges in today’s increasingly complex global economy.

While the industry has strained to keep its supply chain functioning during the last several years, regulatory agencies have been busy implementing very pointed and innovative strategies to understand the root causes of drug shortages.

With all that in mind, ask yourself the following questions: Are my supply chain weaknesses putting patients at risk of not receiving safe, reliable medicines? How can I know? Who can I talk to? Where can I go to get answers?

In “FDA Watch: Is your Supply Chain at Risk?” author Patrick Day, M.S., Principal Consultant, Lachman Consultants, outlines the various factors affecting the regulatory environment and the importance of getting accurate, actionable answers to mitigating your supply chain risk.

With regulatory thinking in place, documents and guidance’s are in flight, and industry leaders now need to integrate them into their long-term strategies. This timely article provides links to a sampling of documents that have been either published or drafted for public comment.