Listen to the individual audio transcripts from this story, featuring Susan J. Schniepp of Javelin Pharmaceuticals, Martin Van Trieste of Rx-360, Janeen Skutnik of
IPEC, Tom Buggy of DSM Anti-Infectives, and Susanne Keitel of EDQM, in PharmTech’s special podcast series.
Martin Van Trieste on Rx-360 and shared audits
Van Trieste is vice-president of quality at Amgen (Thousand Oaks, CA) and interim director of Rx-360, the recently established
international pharmaceutical supply-chain consortium.
(ILLUSTRATION BY DON FRASER/GETTY IMAGES)
We have learned some recent lessons the hard way. The tragedies related to economically motivated adulteration of glycerin
in Haiti, Panama, and Nigeria as well as heparin used in the United States and Europe, and melamine found in various products
throughout the world, have taught us that unethical individuals and criminals have entered the pharmaceutical supply chain
with tragic consequences. The US Food and Drug Administration estimates that at least 800 individuals have died throughout
the world [because of] adulterated glycerin. The number of deaths and serious injuries related to the other events mentioned
is in the thousands.
As regulators and industry professionals, we wake up every morning and decide how our ideas and work will help patients. This
is all undermined by another group of individuals that wakes up every morning to develop methods to pass off cheap substandard
materials to make a quick profit.
About a year ago, FDA and PDA, the Parenteral Drug Association, collaborated to develop a conference series to increase awareness
of this problem and to solicit ideas from industry about how to fight back. Several quality leaders from within our industry
quickly realized that the problem was not due to a failure of good manufacturing practices (GMPs) but was a result of criminal
activity. We also recognized that this problem was global and very complex, requiring a big bold response that no one company
could solve on its own. At the second conference, in December 2008, we decided the best response would come if the industry
joined forces. We decided to form a consortium, which grew into Rx-360.
Rx-360 now has more than 25 members representing pharmaceutical and biotechnology companies, their suppliers, and various
professional organizations. Rx-360 does not intend to compete or duplicate the efforts of other organizations such as the
International Pharmaceutical Excipients Council (IPEC), but rather to collaborate with these organizations to reduce patient
risk as quickly as possible.
There are four functions of Rx-360. First, we are adopting standards and best practices. The consortium will scan external
sources for the best available standards today that will assist in improving the performance of the supply chain. After implementation,
the consortium will look to identify any gaps in the standards aimed at improving these standards.
Second, Rx-360 will conduct supply-chain surveillance. The consortium will act as a clearinghouse for vital market supplier
and supply-chain information. Consortium members will report suspicious and pertinent events to the consortium, which will
disseminate the initial information, evaluate the impact of the information on its members, and develop potential proactive
solutions for its members to consider adopting. By creating an effective surveillance system, we will know about shortages
and other critical events earlier than the criminals.
Third, we will develop technology to prevent or detect adulteration. The consortium will work with research organizations
to develop new technologies that will ... detect if there has been tampering within the supply chain. Finally, we are developing
a process for sharing audit information. We are working on the standards we should adopt, what those standards are, and how
to qualify our auditors. Our goal is to begin sharing audit data between member companies by year s end.
It is important to remember that it is still the responsibility of each member company to make its own decision on a supplier
s acceptability based on its individual product requirements and its own company policies and procedures.
The shared-audit program should reduce the number of audits at common suppliers, eliminating what is known as "audit fatigue."
What we will ask for in return from the suppliers is to allow Rx-360 to conduct longer, more thorough audits that not only
cover GMP but that also look at environmental health and safety, risk management, supply-chain security, and other activities.