Supply-chain integrity is a critical concern for the pharmaceutical industry and its suppliers, and the industry is taking
a step forward by addressing these concerns as a collective whole through the formation of Rx-360. Launched in June, Rx-360
is a nonprofit international pharmaceutical supply-chain consortium whose mission is to create and monitor a global quality
system by adopting standards and best practices for the supply chain, supporting technology developments for supply-chain
security, monitoring the supply chain, and developing shared audit programs.
Nearly 130 industry representatives attended the launch meeting in June to provide feedback on the consortium's objectives
and structure. A voluntary organization, membership in Rx-360 is open to suppliers of raw materials, components, excipients,
and active pharmaceutical ingredients, and pharmaceutical and biotechnology companies. There are already about 10 members
and another 50 or so pharmaceutical and biopharmaceutical companies as well as 13 trade and standard-setting organizations
such as the European Fine Chemicals Group, the Generic Pharmaceutical Association, the International Pharmaceutical Excipient
Council of the Americas, the National Institute for Pharmaceutical Technology and Education, the Parenteral Drug Association,
and the Society of Chemical Manufacturers and Affiliates, had expressed interest in joining.
There will be membership fee, which has not yet been set, but proposals range from $2000 to $20,000 depending on the number
of consortium members. Whether fees will be tiered for large and small companies was also still under discussion at press
The consortium's founding panel members have not publicly disclosed their names or their company affiliations, but Martin
Van Trieste, vice-president of quality at Amgen (Thousand Oaks, CA) is functioning as the consortium's interim director. Van
Trieste addressed the core reason for forming Rx-360 at the launch meeting. "Because the economic gain for adulterators is
great, the pharmaceutical supply chain is at risk. A crisis like the heparin incident will happen again; it's just a matter
of when," he said. "We can't ask regulators to police our suppliers—it's our legal responsibility."
Industry seems to agree. In a live poll conducted at the meeting, 100% of voting attendees said they believe a consortium
like Rx-360 is a necessity in the current environment. Rx-360 plans to address its goals during a three-year period as follows:
- Year 1—Adopt standards and best practices: Rather than add to the extensive list of existing regulations, the consortium intends
to act as an "umbrella" by adopting already existing standards which it feels will improve supply-chain performance. Members
may consider writing new standards in the future if any gaps in standards are identified.
- Year 2—Implement shared supplier audit program: Rx-360 intends to provide to the industry with a wide range of auditing services,
including a system that will allow companies to share audit findings and corrective actions.
- Year 3—Develop technology: Rx-360 plans to work with academic institutions and research organizations to develop related supply-chain
security technologies, such as tools that can detect contaminated or adulterated materials.
- Year 3—Monitoring: The consortium sees itself as a future "clearinghouse for suspicious supplier and supply-chain information
that might impact patient safety," according to the consortium. This clearinghouse, for example, may involve electronic communications
to alert consortium members to potential supply-chain disruptions.
The primary push for Rx-360 is the idea of sharing supplier audit reports. Nearly 80% of participants voting at the launch
meeting said their current audit programs need work. And according to Van Trieste, the head of the European QP Organization
stated that industry would have to conduct 800,000 supplier audits per year to meet current and future regulatory expectations.
Yet, "if just 100 companies would use 50 shared audits, industry could save $50–$80 million a year," said Van Trieste. More
important than the cost savings is that, through shared audits, more information can be obtained about a supplier because
all parties involved are willing to spend more time on the audit—and more information allows firms to make better decisions,
he added. A shared program would also benefit suppliers because they would be able to consolidate multiple customer audits
through a single shared audit.