Newsmakers Interview: Rx-360 ,

The Rx-360 consortium rolled out in June 2009, with the mission to “create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by enhancing product quality and authenticity throughout the supply chain.” Several months earlier, SAFC launched its Vendor Audit Services unit to provide clients with auditor-teams that can cover wider geographic regions than in-house programs.

I spoke with two of the consortium’s founders, Martin VanTrieste, vice president Quality at Amgen, and Tom Beil, vice president of Quality and Regulatory Affairs at SAFC, to talk about Rx-360, globalization,and the challenges of securing one’s supply chain. —GYR

Contract Pharma: What led to the founding of Rx-360?

Martin VanTrieste: It was somewhat of an evolution. Over a year ago, there was a lot of publicity about contaminated raw materials in the supply chain. There was the case in Panama of diethylene glycol in cough syrup, which led to the deaths of children. Then there was the Heparin tragedy here in the U.S., followed by a series of events coming out of China with melamine in pet food, antifreeze in toothpaste, and lead-based paint on toys.

All of that caused a lot of concern in the pharmaceutical industry about our supply chain. The Parenteral Drug Association (PDA) was approached by the FDA to put together a conference that could be taken around the world to discuss security issues in the supply chain. The FDA wanted to get the message out that we need to do a better job, and also to listen to industry to find out what we’re doing and what the hurdles were.

I was asked to present as the closing speaker at that first conference in Washington, D.C., in December 2007. It was probably the most emotionally charged conference I’d ever been to in my life. When I closed out the session, people were crying because of how emotional the meeting became.