Below is a brief update on several Rx-360 Working Groups:
The Audit Operations Group. The Group continues to push forward the Rx-360 Audit Programs through the ongoing educational training programs. The Group is also overseeing and advancing the Top 100 supplier site effort to enhance the number of audits scheduled. Based on feedback from this effort, Rx-360 will begin contacting suppliers to request and schedule approximately 75 priority audits. Another large block of audits will begin the scheduling process later in the year. The Audit Programs Subgroup has been meeting regularly to develop discreet actions to continue to enhance awareness and acceptance of the audit programs. The Group held an in-person meeting on 12 October to develop next steps on getting further involvement from suppliers and sponsors in the audit programs. Members of the Group attended the September in-person meeting of the Database group. The Audit Operations Group continues to review progress of the database, audit programs, new audit firms and auditors, and consider potential new guidelines for use.
The Audit Database Group held a project kick-off meeting in September to commence development of the audit database software. The software development will continue through 2013. The Working Group is in the process of conducting a risk assessment and will then 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. The Group has posted 25 summaries thus far in 2012 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 and continues to attract new members. The Working Group is organizing presentations/booths at several upcoming conferences. Rx-360 will be present at FDA/PDA Pharmaceutical Supply Chain Conference (13-14 November 2012, Rockville, MD) and is planning to present at several events during the first quarter of next year (Informex 19-22 February 2013, Anaheim, CA (including another Habitat for Humanity event) and DCAT 11-14 March 2013, New York, New York). 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 Supply Chain Security Steering Committee has launched four new limited duration working groups addressing illegal diversion, management notification and serialization. The serialization group will focus on knowledge and information sharing regarding this topic. The illegal diversion and management notification groups will develop papers and tools for stakeholders. The Steering Committee held an in-person meeting in late August which included participation of FDA and a presentation from a member of the U.S. Senate Health, Education, Labor and Pensions Committee.
Ad Hoc Group: EU GMP Part 3. In September 2012, Rx-360 formed an ad hoc group on EU GMP Part 3. The group has held several teleconferences that resulted in the following materials: 1) an Rx-360 Memorandum providing background information on the EU GMP Part 3 changes, and made available to all Rx-360 members and posted to the Rx-360 website for public reference (http://www.rx-360.org/LinkClick.aspx?fileticket=vVMmWZeyMBw%3d&tabid=314), and 2) a survey to assess the knowledge and reaction of companies on the EU GMP Part 3 changes (http://hosted-p0.vresp.com/427409/bdaa4c180e/ARCHIVE). The group is also preparing a letter to appropriate regulatory authorities to highlight concerns of Rx-360 members regarding potential consequences of the EU GMP Part 3 changes.
Organizations interested in becoming an Rx-360 Member or Observer should contact the Rx-360 Secretariat at [email protected].