Below is a brief update on several Rx-360 Working Groups:
The Audit Sharing Working Group is conducting its pilot program to share audit reports and responses conducted by individual members of Rx-360. Participating suppliers have collectively proposed to share approximately 165 reports. The Group is now working to collect redacted reports and to convey them to sponsors for review and any further redaction, after which the reports will be entered into the Rx-360 database. The Group has also developed an evaluation guide for assessing the pilot program.
The Auditor Qualification Working Group has sent out a request for cost proposals to a short list of third-party auditing firms being considered for use in the Joint Audit Pilot Program. These cost proposals will be evaluated by the Working Group in early December. Communications have also been sent to the registered auditors not selected to participate in the Pilot.
The Audit Design Working Group has begun contacting suppliers to invite them to participate in the Joint Audit Pilot Program as auditees. The Secretariat is in the process of soliciting further contact information for some of these suppliers. The Working Group has also finalized various template forms and letters, which will be used in the auditing process.
The Audit Standards Working Group has finalized the Rx-360 API Guideline, the Rx-360 Supply Chain Security Checklist, the Rx-360 Basic Chemicals and Raw Materials Audit Guide, and the Rx-360 Excipients Guideline and Audit Guide (which is adopted from the IPEC/PQG excipients documents). The Group is now working to develop or adopt a guideline for packaging materials.
The Audit Database Working Group has launched the database to be used during the pilot audit programs. A user manual and e-learning module related to the pilot database are currently in development. The Working Group is also preparing a Request for Information to obtain more information about options for the long-term database.
The Quality Management System (QMS) Working Group has finalized the QMS for the pilot programs and is now developing a QMS for the established Rx-360 programs, as well as associated SOPs, templates and other necessary documents. The Group has also developed an orientation program for 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 twenty 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 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 planning for an Open Meeting to be scheduled in the US in May 2011.