Below is a brief update on several Rx-360 Working Groups:
The Audit Operations Group has developed three new options for the existing Joint Audits process, which aim to facilitate faster agreement with suppliers, scheduling, potentially lower costs and less complex materials scope. These options will be piloted by interested companies (initially those participating directly in the Audit Operations Group) in the next several weeks. The group aims to provide an interim update on feedback from these pilots at the October Board meeting. The options are (i) sponsors get agreement to conduct a Joint Audit with the supplier and agree on a date – other sponsors are asked to join; (ii) sponsors conduct their own already planned audits using an Rx-360 approved audit firm, and submit the audit reports on the Joint Audit template, which are entered into the audit database for licensing; and (iii) suppliers can request a Joint Audit of their sites, and specify potentially interested member sponsors and materials to be audited. The options were developed based on responses to several surveys that the group developed to obtain feedback on the Joint and Shared Audit programs and establish continuous improvement of the programs, as well as input from group and Board members.
Currently the Joint Audits program is on track to conduct two times as many audits as in 2012. As of this year, 17 Joint Audits have been scheduled and/or completed in Asia, Europe, the Middle East and the United States. Twenty-eight Joint Audit reports and one shared audit report have been licensed.
The group continues throughout the year to gather feedback through its surveys. Additionally, the group conducted two webinars in May – one for US/Europe/South America and the other for Asian regions – to provide Consortium lead audit contacts with updates on the current and emerging key issues related to the Audit Programs and to gather input from attendees.
The group has established an Auditor Management Working Group to provide oversight and regular feedback to the auditors/audit firms engaged by Rx-360 to conduct audits. The group has also established the Quality Management limited duration working group, which is updating the Rx-360 Quality Management System (QMS) and developing a draft quality agreement between Rx-360 members/audit sponsors and Rx-360 in response to current EU legislation.
The Audit Operations Group is also reviewing and providing input into the development of the audit database. Development of the Rx-360 Audit Database commenced in September 2012 and is expected to be completed ahead of schedule in the summer of 2013. The database is expected to be launched in October 2013, upon completion of testing and validation. Additional information on database training will be circulated closer to the launch of the 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. In addition to reporting on key supply chain developments, the Monitoring and Reporting Working Group also periodically provides brief, high-level updates on other topics of interest to Rx-360 members and not specific to the supply chain (for example GDP/GMP). The working group has posted 109 summaries since its inception (including 28 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 to the pharmaceutical, supply chain and regulatory communities with information on Rx-360’s activities. The Rx-360 Membership Committee continues to attract new members.
The Supply Chain Security Working Group continues to drive the agenda around improving the security of the global pharmaceutical supply chain. A number of whitepapers have been published in 2013 that deal with key issues in this area:
The group has launched three new efforts: (i) An upstream supply chain security threats working group; (ii) a cargo theft in high-risk areas working group; and (iii) a security-related, data-sharing feasibility group, all of which are actively meeting via teleconference. The committee also initiated a small group to address education for healthcare providers, which includes participation from FDA. Their educational materials and efforts have received positive feedback from stakeholders. Committee members continue to participate in international conferences to educate and inform on supply chain security issues and Rx-360 efforts in this area, including the recent PDA/FDA supply chain conference on 4 June. The Committee is also providing input into the formation of an Rx-360 Asia group, which will initially focus on supply chain security topics.
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, which has been posted to the Rx-360 website, and 2) an educational webinar on the topic, which attracted 140 attendees and can be viewed online.