Rx-360 implements pilots for new audit programme options

Published: 30-Aug-2013
Regulatory

An important step in continuous improvement of supply chain security programmes


Rx-360, an international pharma industry consortium, has added new pilot programmes to its Joint Audit offering, which aim to provide alternative ways to initiate and conduct such audits.

Rx-360 is also starting work on a pilot to conduct Good Distribution Practice (GDP) distributor audits.

These new options are a result of ongoing survey feedback from organisations participating in the audit programmes and Rx-360 members generally.

Option 1 allows a sponsor and supplier to agree on a date and scope of a Joint Audit as a first step in the process. The audit scope and date is then offered to other member companies for co-sponsorship. This option aims to speed up the scheduling process by gaining supplier agreement up front, as well as date and scope specifics early in the process.

Option 2 allows individual sponsors to conduct their own scheduled audits and submit the results as Rx-360 Joint Audit reports. The audits would be carried out by one of the Rx-360 accepted auditing firms. The option allows sponsors to provide individual reports to the Joint Audits database, with the possibility of licensing the reports.

Option 3 allows a supplier to initiate a Joint Audit, identifying a date and scope of the audit, which is then offered to potential sponsors.

In parallel, Rx-360 is developing the infrastructure for conducting pilot GDP audits of distributors. This includes identifying qualified audit firms, and appropriate audit guidelines and/or standards.

'In addition to the new audit offerings, we are also very close to implementing a new IT audit database which will streamline our internal audit scheduling and management processes,' said Wes Schmidt, Vice President of Abbvie Operations and Quality Assurance, and Rx-360 Board Member.

'We recognise the challenges and complexities of offering an outsourced audit programme and thanks to the hard work and dedication of the audit committee and board volunteers; we have reached an important big first step in continuous improvement of programmes required to assure the supply chain is as safe and secure as possible.'

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