The Audit Operations Group (AOG) is starting to collect information on experiences with the audit programs through several targeted electronic surveys that will be conducted in association with scheduling and performance of audits. Information from the surveys will be used to make improvements to the programs as well as to target areas for further outreach and education on the programs. In parallel, joint audits continue to be scheduled and shared audits continue to be submitted. The Group initiated regular communication and webinars for consortium lead audit contacts to keep contacts apprised of new AOG initiatives. The Group held two informational webinars for lead audit contacts in February and will continue these throughout the year along with informational webinars for the general Rx-360 membership and for non-members. The Group worked with the membership committee to develop further information for companies being audited to place on the Rx-360 website, including a summary flowchart describing key aspects of the joint audits process. The Audit Operations Group is also reviewing and providing input into development of the audit database.
The Audit Database Group held a project kick-off meeting in September 2012 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 global 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 guidance and proposed legislation of interest to the Rx-360 community, but not directly related to supply chain issues. The Working Group has posted 90 summaries since its inception (including 9 thus far in 2013) and it continues to serve as an important resource.
The External Relations/Regulatory Affairs Working Group continues to provide regular updates on Rx-360’s activities to the pharmaceutical, supply chain and regulatory communities and continues to attract new members. The Working Group has organized presentations/booths at Informex February 19-22, 2013, Anaheim, CA (including another successful Habitat for Humanity event) and DCAT March 11-14, 2013, New York, New York. The Working Group, in coordination with the Board, works to ensure that Rx-360’s initiatives are aligned with regulators’ expectations and priorities; the group is also 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 Rx-360 Membership Committee held an Information webinar on January 28. The webinar can be viewed at: http://youtu.be/GMUsGMWpcso. Future Informational Webinars will be scheduled throughout 2013.
The Supply Chain Security Steering Committee is finishing up deliverables through its illegal diversion and management notification working groups. Its serialization discussion group continues to share experiences and knowledge on its regular teleconferences. The Committee is considering establishing some new limited duration working groups. The Committee is driving Rx-360’s participation in APEC supply chain related working groups. The Steering Committee held and in-person meeting at the end of February which included guest speakers from FDA and the US Department of Commerce addressing APEC and international supply chain security initiatives, and Drs. Amir Attaran (University of Ottawa) and Roger Bate (American Enterprise Institute) speaking about their research and findings related to international pharmaceutical supply chain security.
Ad Hoc Group In September 2012, Rx-360 formed an ad hoc group focused on the Falsified Medicines Directive and API Importation into the European Union. The group has produced the following deliverables: 1) an Rx-360 Memorandum providing background information on the EU GMP Part 3 changes has been posted to the Rx-360 website (http://www.rx-360.org/LinkClick.aspx?fileticket=vVMmWZeyMBw%3d&tabid=314), and 2) an educational webinar on the topic, which attracted 140 attendees and can be viewed online at: http://www.rx-360.org/Resources/Webinars/tabid/358/Default.aspx#4.