The drug quality and authenticity nonprofit Rx-360 has launched its audit sharing program, through which members collect and share details of their findings from suppliers' investigations. Members can use the reports to identify and pre-screen suppliers, according to an Rx-360 statement.
Overall, the program offers savings to drugmakers by cutting back on the amount of legwork involved in qualifying suppliers. The evaluation of audit reports and supplier responses can help reduce the frequency, length and scope of the vetting process by arming auditors with pertinent information before they arrive on site.
For their part, suppliers get visibility to potential customers and the eventual possibility of reduced pre-audit paperwork, according to the statement.
The program launch follows a pilot that ended in July.
Audit-results sharing is becoming a new weapon among those charged with ensuring a safe drug supply--manufacturers and regulators alike. In August, the FDA reported the results of its collaboration with European and Australian regulators in a pilot of cross-border cooperation that could amount to a regulatory force-multiplier to keep up with the explosion of drugmakers in developing countries.
The effort involved not just information sharing, but also inspections conducted jointly by more than one regulator. Their focus was API makers. The regulators agreed to continue their efforts and eventually extend the program.
- here's the Rx-360 release