Happy 5th Birthday for RX-360; industry group takes a big step forward in collaborative audits

Rx-360, the industry consortium formed in the aftermath of the heparin scandal in 2008 (in which contaminated, raw heparin sourced from China entered finished products and caused multiple deaths in the US and Europe), chose the PDA/FDA Supply Chain Conference (Washington, DC; June 3-5) to celebrate its fifth birthday. While the organization’s original goal—to both accelerate the auditing of suppliers to pharma manufacturers and reduce audit cost and complexity by pooling audit results—remains a driving force, the organization has expanded its scope by generating recommended guidances on many aspects of the pharma supply chain, including quality management, cargo security and others.

At the same time, Rx-360 made a key announcement pertaining to its audit activities. It has chosen BSI Supply Chain Solutions (US HQ, Scottsdale, AZ), part of the larger BSI Group, a global auditing, training and certification company that operates across multiple industries, to manage its Joint Audit Program. BSI SCS will conduct audits, provide training and coordinate activities sponsored by Rx-360. BSI SCS has a proprietary auditing process, called VerifEYE, that will be deployed on behalf of Rx-360.

"Rx-360’s primary mission is to ensure patient safety by maintaining high standards of quality during the manufacturing process," said Ben Mills, co-chair of Rx-360’s audit operations group, in a statement. "The Joint Audit program will allow consortium members to pool resources and have third-party audits conducted simultaneously while protecting commercially-sensitive and proprietary information. The Joint Audit Program offers consortium members, suppliers and manufacturers alike, the opportunity to reduce the audit burden while amplifying product confidence and safety."

Rx-360 has 28 manufacturers, 35 suppliers, 13 auditing organizations and 18 industry associations as members currently.