Rx-360 was incorporated as a non-profit organization in June of 2009 and currently has more than 40 member organizations (suppliers, professional organizations, biotechnology and pharmaceutical companies).
Rx-360 is designed to be all inclusive, including branded and generic manufactures, large and small companies, suppliers, vendors and professional organizations. The consortium plans to: 1) adopt standards and best practices; 2) encourage technology development; 3) monitor and share global legislation, regulation and suspicious events around the world; and 4) share supplier audits.
Rx-360 has nine active working groups focusing on creating infrastructure, monitoring the global environment, sharing information and sharing audits. During the past several months, Rx-360 members have been busy setting up the infrastructure to initiate pilot programs to conduct Rx-360 lead audits and to collect existing audit reports and responses. To date, the Consortium has:
- developed a guideline for APIs, a supply chain security checklist and is drafting a guideline for basic chemicals and raw materials;
- designed the overall audit process for Rx-360 lead audits for the pilot program, and created documents and protocols needed to implement Rx-360 lead audits as well as follow-up measures (CAPAs, etc);
- developed an approach to requesting and qualifying auditors;
- developed a prototype database to hold audit information from the pilot program, and is developing user requirements for and approaches to identifying a more mature database platform;
- designed a process for collecting existing audit reports and responses; and
implemented an overall quality management system for the pilot programs.
The Consortium is currently on track to implement its pilot programs within the first quarter of 2010. Information from these pilot programs will be used to assess feasibility, effectiveness, and potential gaps and areas of improvement in the proposed programs.
Concurrent with these audit related activities, Rx-360 is actively monitoring and sharing with its members updates on relevant regulatory and legislative developments, and current events regarding pharmaceutical quality. The Consortium continues active outreach to the pharmaceutical, supply chain and regulatory communities to provide information on its activities, and invites suppliers, pharmaceutical manufacturers and other interested organizations to become Consortium members and participants. Rx-360 is accepting new members and welcomes your participation.
For more information on membership please contact: Rxemail@example.com.