Our mission is to protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of its materials.
With a focus on building strong partnerships between pharmaceutical manufacturers and suppliers, Rx-360’s goal is to ensure the integrity of supply chains through member led working groups and audit program.
We are a community of life-science and medical device thought leaders committed to driving positive change within the industry.
In 2008 a meeting with pharmaceutical industry executives and Janet Woodcock, director of the U.S. Food & Drug Administration’s Center for Drug Evaluation & Research (CDER) at the time, was convened following the heparin contamination that year that was responsible for 81 deaths in the U.S.—an event that brought the issue of drug safety and supply-chain security to the forefront.
After this meeting, Rx-360 was formed.
Join Audit Program
The audit program allows cosponsorship of audits in a confidential manner.
As supply chains become more global, complex and increasingly vulnerable to adulteration and counterfeiting, Rx-360 has increased its focus on strong partnerships between pharmaceutical manufacturers and suppliers to ensure the integrity of supply chains through on-site auditing.
Currently, the Rx-360 Joint Auditing Program includes audits of suppliers of APIs, excipients, basic chemicals and raw materials, packaging components and Good Distribution Practices (GDP), single use systems, supply chain security, contract laboratory, and software vendors. The Rx-360 Joint Audit Program allows one or more Rx-360 member(s) or nonmember(s) to request an audit of a particular supplier. Rx-360’s team of qualified auditors begin the process and produce a finalized report on findings and observations. Members can view audits in real-time and all audit reports generated through the Rx-360 Audit Program can be utilized by licensees.