After the completion of the Joint Audit Pilot, the Board of Directors agreed to merge the audit program working groups into the new Audit Operations Group. Exceptions to this include the Auditor Qualification and Audit Database Working Groups, which are completing tasks previously set before them.
The Audit Operations Group consists of 13 members. At least one member of each of the previous audit working groups is acting as a primary member. Secondary members were nominated through their organizations. At the end of one year, secondary members will replace primary members and new secondary members will be nominated.
The Working Group has met twice, addressing issues related to the auditing programs and the database. Clare Gosling of AstraZeneca will co-chair this group with another member to be named.
The Auditor Qualification Working Group conducted an auditor orientation webconference to update the three auditing firms used in the pilot on new procedures and documents put into place for the Joint Audit Program. Six additional auditing firms have been approved to participate in the Joint Audit Program. An orientation session for the new auditing firms is being scheduled for April. The SOP has now been completed and signed. As the Working Group finishes their review of registered auditing firms, they will merge into the Audit Operations Group. The final meeting for the Working Group was April 4th.
The Audit Database Working Group reviewed the responses received in January to the Request for Proposals and selected five potential vendors to present at a face-to-face meeting at the DBR Offices in Washington, DC, the first week of April. A recommendation on a long-term database solution will be presented to the Audit Operations Group and the Board of Directors following the presentations. The Working Group has also been working to create a validation plan for the new database.
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 Working Group also periodically prepares brief, high-level updates on regulatory updates of interest to the Rx-360 community, but not directly related to supply chain issues. Since 2011, the group has posted 64 summaries and they continue to serve as an important resource.
The External Relations/Regulatory Affairs 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, including ChemSpec (8-9 May 2012, Philadelphia, PA), CPhI (9-11 October 2012, Madrid, Spain) and FDA/PDA Pharmaceutical Supply Chain Conference (13-14 November 2012, Rockville, MD). The Working Group also 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 Japan Supply Chain Working Group continues to meet as necessary to discuss current or emerging changes in regulatory requirements, and industry activities and experiences related to the effects of the 2011 Japan earthquake/tsunami.
The Supply Chain Security Steering Committee and its four working groups on Management Systems (to describe a mature supply chain security system); Audits and Assessments of Third Party Providers; Market Monitoring; and Conveyance Risk Management; are moving forward quickly with their deliverables. All groups are developing white papers, models and tools which will be made available to the industry either through publications and/or through the consortium website. The Management Systems and Conveyance Risk Management are targeting Board review of their deliverables in the next few weeks. The Steering Committee held a March face to face meeting in which a representative from the FDA Office of Drug Security Integrity and Recalls participated.