Pharma Industry Consortium Rx-360 Tackles Supply-Chain Security - Pharmaceutical Technology

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Pharma Industry Consortium Rx-360 Tackles Supply-Chain Security
Supply-chain integrity is a critical concern for the pharmaceutical industry and its suppliers, and the industry is taking a step forward by addressing these concerns as a collective whole through the formation of Rx-360.

Pharmaceutical Technology

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 this model.

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.


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