Rx-360 is proposing three types of shared supplier audits. The "sponsored" model involves a consortium member company paying
for Rx-360 auditors to conduct an audit of a supplier of their choice. This model is essentially a third-party audit system,
which benefits smaller pharmaceutical and biopharmaceutical companies that do not have their own audit staff as well as larger
companies who want to audit a supplier in a region where they do not have audit coverage. Once completed, the audit report
would go into the consortium's shared audit database so that other members could purchase it. Sixty-seven percent of voting
participants at the launch meeting said they support this model.
The "Rx-360" model would involve a joint decision among a certain number of consortium members to audit a supplier. Once an
Rx-360 team completes the audit, the members that requested the audit would receive the audit report. In addition, the report
would go into the shared audit database for purchase by other members. The Rx-360 model was the group favorite at the launch
meeting, with 90% of voters supporting the idea as a viable approach.
The "subscription" model would allow consortium members to submit and pull from a shared database audit reports that have
already been conducted, either by their own company or by a third-party. Eighty-one percent of launch meeting voters support
Although there is great support for Rx-360's proposals, there is a lot of work to be done before a shared audit program can
be finalized. During breakout sessions at the launch meeting, industry representatives discussed some concerns about sharing
audit reports. For example, what would be the qualifications of the Rx-360 auditors? Would there be an agreed-upon template
for audit questionnaires? Given that different companies manufacture different types of drugs, would an Rx-360 audit or another
company's audit fulfill a different member company's audit needs?
Reflecting these concerns, 16% of the voting participants at the launch meeting said shared audits were not an option, and
another 33% said shared audits would require significant rework. That said, the remaining participants seemed very open to
working with the current proposed program and its models. One potential solution discussed during the breakout sessions was
that consortium members use an Rx-360 audit report as an initial assessment for their company to determine to what extent
additional review or time is needed for their own audit of a particular supplier.
During the next few moths, the Rx-360 advisory panel and consortium members have their work cut out for them. Priorities,
according to Van Trieste, will be to grow membership; review and address feedback received from the Washington, DC, launch
meeting; form various committees to build the consortium's infrastructure (i.e., adopting audit standards and selecting a
secure database to use); and arranging for a European launch meeting.
To listen to a podcast interview with Martin Van Trieste, log onto the podcast page and register.