Supply chain security organisation
Rx-360 has said that its joint audit programme is now operational
following a successful pilot phase.
The programme allows member companies to share the costs of audits with other companies while reducing the number of audits suppliers need to host in a year. Audit reports may be purchased through Rx-360 with the permission of the audited supplier.
During the pilot phase, 19 audits were conducted in three regions of the world, including the US, Europe, China, India and Japan. The scope of the pilot audits included raw materials, excipients, chromatography resins and active pharmaceutical ingredients.
Three third-party auditing firms conducted the audits using standards which Rx-360 had adopted, including the recently-launched EXCiPACT standard for excipient audits and a supply chain security checklist for all suppliers. Since the pilot, audit standards have also been adopted for packaging material suppliers.
Martin Van Trieste, previous chair and current treasurer of Rx-360 and senior vice president, quality at Amgen, said: "Amgen is excited about the joint audit programme and will accept Rx-360 joint audits in lieu of an Amgen conducted audit."