Rx-360 is an industry consortium founded in 2009. Our mission is to ensure patient safety by enhancing the authenticity and quality of medicines around the world. To do this, Rx-360 embraces everyone: large and small pharma; innovators and generic manufacturers; CDMOs, suppliers, drug manufacturers and device manufacturers; producers of APIs, excipients and packaging materials — whether regulated or non-regulated; providers of logistic services and analytical services; dosage form manufacturers and producers of chemicals and intermediates — any organization that is involved in the healthcare supply chain is welcome.
Rx-360 has no home country; it was designed from day one to be global, to welcome all organizations from all nations and all cultures. Our member companies have sales that add up to half a trillion dollars, supply close to half of the world’s prescription drugs and come from all the major countries. Rx-360 is active not just in the developed world; we have specific working groups that focus on India, China and Africa.
The Rx-360 Difference
Rx-360 members know that working together is the only way to successfully improve the security and authenticity of the global medicines supply chain. Rx-360 is open-minded, transparent and collaborative. Volunteers are motivated by an important goal: protecting the patient and working to stop criminals who take advantage of the trust in medicines that has taken us a hundred years to build. Regulators trust us because we do not defend the interests of our member companies; rather, we exist to protect the patient.
Rx-360 provides procurement professionals with an early-warning forum. Indeed, back in the summer of 2007, six months before anyone died of falsified heparin, the price per kilo of heparin exported from China had trebled in price — this was a big red flag that could have helped save those patients’ lives, had it been tracked.
Rx-360 Benefits
A central part of the vendor qualification process is the quality audit. While necessary, audits are repetitive and tedious. They are disruptive and costly. Rx-360 is able to assure increased compliance and to provide timely access to valuable data while reducing the frequency of audits and auditing costs.
Shared Audits
Our members post onto our database the suppliers they want to have audited. When more than one pharma company wants to audit the same supplier, a shared audit is flagged. The cost of the audit may be divided between two, three or more sponsors. After closure, the audit report is put into our audit library, with a CAPA plan in place, and can be further licensed to any company the supplier authorizes. If the reader visits our website, the visitor can see the audit report library available for licensing. Depending on membership, the license fee for one audit report ranges from $2,500 to $5,000 (USD).
Supply Chain Security
Did you know that every week, just about every major pharmaceutical company has cargo stolen? This occurs frequently in Brazil and Mexico but also almost everywhere else too, including the USA. These thefts occur in patented as well as off-patent medicines. Did you also know that donated medicines are often diverted by recipients and then sold in other countries?
Rx-360 works on cargo thefts, access to medicines, and a host of other issues related to supply chain security. As possibly the only forum that embraces everyone, Rx360 is designed for the sharing of experiences and for the development of best-practice white papers.
For example, Rx-360 recently completed the fourth of its international GDP programs in Africa. These meetings of our Africa GDP working group have been oversubscribed. We look forward to the next one, which will be in November, in the Ivory Coast.
I Invite You to Join Us in Helping Protect Patients
We need YOU — as a member company and as a volunteer. Over 300 individuals from around the world contribute to making Rx-360 a vibrant pharmaceutical and medical device ecosystem, and we all do this in addition to our full-time jobs.
There is no better networking environment. With over 17 different working groups in Rx-360, one of them will surely align with your day job!
Rx-360 is open to all. Joining has a low annual price tag ($30,000 for pharma manufacturers, $12,000 for small pharma manufacturers and $6,000 for suppliers). Industry associations, regulators and other interested parties may join for free as observers.
Come and join us. We are doing amazing things and making a real difference for patients worldwide. To join and for more information, please email Mark Paxton, Rx-360’s CEO, at mpaxton@rx-360.org or visit www.rx-360.org.