Many companies throughout industry are depending on Rx-360, the international pharmaceutical supply-chain consortium launched last year, to help ease the burden of protecting their ever-lengthening supply chains.
Two goals of the consortium are now getting underway. First, Rx-360 announced earlier this week that its members are beginning to share existing sponsor audits through its shared-audit pilot program. The pilot involves 30 suppliers around the world. Because the number of audits a drug sponsor is required to conduct can be in the thousands, obtaining information from other companies who have already conducted an audit at a particular facility may provide very useful information. With this additional information, a company may be able to conduct a shorter, less-intrusive audit on its own—or forego one altogether—thus, saving time and money.
During Rx-360 talks, some industry members have said it’s no problem to look at other companies’ audits—everyone likes free stuff—but the idea of handing out their own audits is a bit more challenging, especially in an industry so flooded by IP rights and patent protection. It will be interesting to see in the coming months how useful the sharing of audits is and whether more companies become more wiling to share their information.
The second achievement for the consortium, also announced by the group this week, involves the adoption of audit standards. Since the beginning, Rx-360 has said it intends to adopt already existing, qualified standards and guidelines rather than setting its own. The consortium will only develop standards in areas where it feels there is a need. For example, groups such as IPEC already have many useful guidelines related to the supply-chain that have received input and approval from FDA and are being used by industry.
The consortium has an Audit Standards Working Group with 27 participants, representing 19 companies and organizations. The group is looking at standards for APIs, excipients, supply-chain security, basic chemicals, packaging, and print. The standards will be used in a pilot to prove the auditing process, according to Mar. 3 Rx-360 release.
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