Green light for Rx-360 audit sharing pilot
05-Mar-2010
The pilot phase of an ambitious scheme aimed at allowing pharmaceutical manufacturers to share audits of suppliers has got underway, according to the Rx-360 consortium.
The aim is to reduce the enormous burden levied on both suppliers and manufacturers of auditing for quality, security and other processes, as well as to reduce the chances of substandard, adulterated and counterfeit materials entering the supply chain.
Rx-360 is an industry consortium which tackles issues related to supply chain security and is trying to bring drugmakers, suppliers, distributors and brokers into alignment with a global, consistent and auditable set of quality standards.
The consortium's Audit Standards Working Group, which consists of a mix of people from suppliers and the pharmaceutical industry, met last month to continue work on developing standards that will be used in the pilot.
The WG has six sub-groups covering: active pharmaceutical ingredients (APIs); excipients; supply chain security; basic chemicals; packaging and print. Standards are being finalised for the first four of these, according to Rx-360 chair Martin van Trieste, who is vice president of quality at US biotech Amgen.
The first phase of the project is to gauge the value of sharing the existing body of supplier audit information that already exists within consortium member companies, said the group in a statement.
The effort got underway last August and will try to pool audits for 30 suppliers across North America, Europe, China and India. The suppliers have been invited to participate in the pilot and will be polled in the coming weeks "to confirm participation and discuss questions," according to Rx-360.
Rx-360 is planning to expand the shared auditing programme in future to include not only existing reports but also prospective audits. These could be prepared either by a sponsor company or a third-party auditor appointed by Rx-360 and would be accessed via a subscription service.
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