Rx-360 Update

Below is a brief update on several Rx-360 Working Groups:

The Audit Sharing Working Group completed its audit sharing pilot program, assessed pilot results and data, and has developed a process and supporting materials for an on-going Rx-360 audit sharing program.  The program will be launched during the week of 19 September.  All Rx-360 member companies are encouraged to participate in this program.

The Auditor Qualification Working Group is focused on evaluating auditing firms for the Joint Audit Program.  Once the auditing firm pool has been established, a matrix of auditor costs per region will be developed to assist in matching auditing firms to prospective audits.  The working group will continue to evaluate CVs of new auditors associated with the approved auditing firms.

With the pilot program nearing completion, the Audit Design Working Group met with Working Group Leaders to review the Joint Audit program.  Feedback gained from suppliers, auditors and peer review panel members was used to streamline the post pilot process.  The online system for requesting audits was opened to the membership in July.  Requested audits were circulated to members who were asked to identify those they want to jointly sponsor.  The first post pilot audit is in the planning stages for fourth quarter this year.

The Audit Standards Working Group Packaging Subgroup is developing an audit guide based on the ISO 15378 standard for primary packaging and will also consider the possibility of adopting the PS 9000:2011 guideline. The Chromatography Resins Subgroup has completed and finalized the appendix on resins for the basic chemicals and raw materials audit guide.  The Board has approved the document, and it will be posted on the Rx-360 website.  The Audit Standards Working Group continues to liaise with EXCiPACT on adoption of the EXCiPACT standard for excipients, and is revising the Supply Chain Security audit guide based on feedback from the Joint Audits Pilot Program. 

The Audit Database Working Group continues to examine options for a long-term audit database for Rx-360. Among the options being considered is whether software and hosting must be provided by the same vendor.  The group aims to be able to present its final recommendation to the Board later in the Fall, for implementation during 2012.

The Quality Management System (QMS) Working Group is holding a 2-day in-person meeting prior to the September Board meeting, to draft and finalize the Rx-360 QMS for the post-pilot audit programs, finalize SOPs for the Joint and Shared Audits Programs, and continue developing a new organizational structure for the Rx-360 auditing functions going forward, as a proposal to the Board.

The Monitoring and Reporting Working Group: updates on this Working Group are highlighted in an article below.

The Regulatory Affairs Working Group engages regulators around the world in order to facilitate constructive relationships and keep them informed of Rx-360’s activities.  The Working Group, in coordination with the Board, works to ensure that Rx-360’s initiatives are aligned with regulators’ expectations and priorities and are keen to solicit and respond to feedback from regulators.  Rx-360 has engaged with numerous regulatory representatives, including from PIC/S, US FDA, EMEA, MHRA, and Irish Medicines Board.

The External Relations Working Group continues to provide regular updates to the pharmaceutical, supply chain and regulatory communities with information on Rx-360’s activities.  Rx-360 continues to attract new members.  The Working Group is organizing presentations/booths at several upcoming conferences.