The Current State of Supply Chain Security: An FDA Perspective


BioPharm International recently interviewed Richard L. Friedman, Director of the Division of Manufacturing & Product Quality in the Center for Drug Evaluation and Research at the FDA’s Office of Compliance, who discusses the progress made so far in executing bio and pharma supply chain security programs.  Friedman speaks positively about Rx-360, of which SAFC is a founding member, stating that the “FDA is very much in favor of industries’ cooperative efforts, such as Rx-360…”

Rx-360 was launched in June 2009 as ‘The International Pharmaceutical Supply Chain Consortium’ and is made up of regulators, pharmaceutical executives, supplier executives and members of professional organisations whose common aim is to serve patients.  Its mission is to create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by guaranteeing product quality and authenticity throughout the supply chain.

Commenting on the interview with Friedman, Tom Beil, Vice President of Quality & Regulatory Affairs for Sigma-Aldrich, said:In recent years, increased attention has been given to risk management and supply chain integrity due to high profile quality issues.  While quality assurance and product safety have always been paramount concerns within the industry, it’s vital that we continue to work towards maintaining stringent requirements and seek to adopt increasingly innovative approaches to ensure that critical quality and supply chain integrity issues are addressed.  It’s very encouraging that the industry initiatives, such as Rx-360 are both recognized and supported by the FDA.”

To hear the entire interview go to the following link

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