Rx-360 continues to make progress on developing an appropriate and effective process to share supplier audits and conduct joint audits. As outlined below, the Consortium is taking steps to implement pilot programs which will provide the organization information to assess feasibility, effectiveness, and potential gaps and areas of improvement for shared supplier audits and joint audits.

The Audit Sharing Working Group has initiated a pilot phase. All member suppliers have been contacted and the Working Group has conveyed to these companies the relevant agreements, process, and background information. The Working Group has also contacted non-member suppliers and is actively following up with these companies.

The Auditor Qualification Working Group refined minimum qualification requirements for third-party auditors to conduct Rx-360 Joint Audits and opened online auditor registration sites and started the selection process for the Pilot.

The Audit Standards Working Group has finalized an Rx-360 API Guideline and a Supply Chain Security Checklist for use as a supplement with other standards in all Rx-360 audits.  The Working Group is also (i) developing an Rx-360 Basic/Chemicals and Raw Materials Guideline and Checklist; and (ii) reviewing the IPEC/PQG Draft Excipients Guideline for purposes of developing an Rx-360 Excipients Guideline and Checklist.

The Audit Design Working Group has finalized all forms and templates needed for the Joint Rx-360 Audit Program and conducted member surveys to identify suppliers of APIs, excipients and raw materials/basic chemicals - from North America, Europe and Asia (including India, China and Japan - as candidates for the Joint Audit Pilot program).

The Audit Database Working Group is reviewing a new software extranet option for managing the pilot audit reports and other related materials. The Working Group is also developing a long-term plan for the post-pilot audit database.

The Quality Management System (QMS) Working Group has held coordinating teleconferences with all Rx-360 Audit Program Working Group leaders. The Working Group has also  developed an Audit Program Management Table listing key deliverables and timelines for all Rx-360 audit program working groups. The Working Group has prepared a high-level QMS describing the key aspects of the proof-of-concept pilots for the Rx-360 Auditing Program and Audit Sharing Program. In addition, the Working Group has prepared drafts of a Quality Policy, an Ethics/values statement, a training approach (with associated documents) for auditors, and a framework for evaluating the pilot programs.