|Rx-360 continues to make progress on developing an appropriate and effective process to allow members to share supplier audits and conduct joint audits. Securing an advisory opinion from the US Federal Trade Commission (FTC) has been a priority for Rx-360 during May and June 2010. Drinker, Biddle & Reath, Rx-360 Legal Counsel and Secretariat, is in the process of requesting an FTC advisory opinion concerning Rx-360's proposed Audit Sharing and Joint Auditing Programs. A draft of the 'official' Rx-360 request for an FTC staff opinion was submitted to the FTC on Thursday, 1 July 2010. The Consortium expects quick feedback from the FTC if any aspect of the proposed process appears problematic or needs to be changed. Once the FTC issues a staff opinion, Rx-360 will launch its pilot programs. Below is a brief update on several Rx-360 Working Groups:
The Audit Sharing Working Group has initiated a process for establishing the Rx-360 Audit Sharing Pilot (to share existing audit reports). 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 is also contacting non-member suppliers and is actively following up with these companies. No audits will actually be shared among members until Rx-360 receives a favorable FTC opinion.
The Auditor Qualification Working Group and Audit Design Working Group’s leadership selected suppliers of excipients/raw materials and basic chemicals for the Joint Audit Pilot. Further steps are on hold pending discussions with the FTC. The AQWG will also prepare a communication to the registered auditors to explain the delay in the start of 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 has also developed an Rx-360 Basic Chemicals and Raw Materials Audit Guide, and is working with the IPEC/PQG to discuss adoption of its excipients guideline for Rx-360, as well as the use of the IPEC/PQG excipients audit guide as a basis for the Basic Chemicals and Raw Materials Audit Guide.
The Audit Database Working Grouphas finalized a protocol and testing plan for the database to be used during the pilot audit programs. The Working Group is also developing a long-term plan for the post-pilot audit database.
The Quality Management System (QMS) Working Group has drafted a formal quality management system for the pilot programs (joint auditing and audit sharing), and has developed a Quality Policy, an ethics/values statement for auditors and volunteers, and a framework for training auditors.
The Monitoring and Reporting Working Group continues to promote rapid sharing of important regulatory, legislative and policy developments relevant to supply chain integrity and pharmaceutical quality by preparing timely, summary analyses which are publicly available on the Rx-360 website. The group has posted more than a dozen summaries this year and they serve as an important resource.
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 Groupis committed to external outreach and regularly updates the pharmaceutical, supply chain and regulatory communities with information on Rx-360’s activities. Rx-360 continues to attract new members — over 40 organizations are now members.
Please note that Rx-360 will host an Open Meetingfor non-members to learn more about the organization, its progress in 2010 and its 2011 plans. The Rx-360 Open Meeting will take place on Thursday, 16 September 2010 in Darmstadt, Germany (hosted by Merck KGaA). The Open Meeting will include presentations by Rx-360 leaders as well as supply chain integrity presentations by invited guests. There will ample time for questions and information gathering and we encourage non-members to join us at this meeting and learn more about Rx-360.
If you would like more information on membership or are interested in attending the RX-360 16 September 2010 Open Meeting in Darmstadt, Germany, please contact the Rx-360 Secretariat at Rxfirstname.lastname@example.org.