Safeguarding The Pharma Supply Chain: A Progress Report On The Rx-360 Consortium

Ben Mills, pharmaceutical technical lead for the British Standards Institute (BSI), delivered an update on the Rx-360 pharmaceutical supply chain consortium at the recent Xavier Health PharmaLink conference in Cincinnati. Mills is former co-chair of the Rx-360 Audits Operations Group, and BSI now serves as the official audit partner of Rx-360, so he has a unique perspective on the consortium and its mission — to protect patient safety by sharing information and developing processes to improve the integrity and quality of materials in the healthcare supply chain. Life Science Connect caught up with Mills to ask him about Rx-360’s activities, its challenges, and its next steps in confronting the high-risk threats to the pharma supply chain.

Life Science Connect (LSC): Please provide a brief introduction to Rx-360, for readers who are unfamiliar with the consortium.

Ben Mills, BSI: Rx-360 has been dedicated to pharmaceutical supply chain excellence since 2009. The nonprofit consortium is led by manufacturers and suppliers from the pharmaceutical and biotech industries who volunteer to enhance the security of pharmaceutical supply chains. Together, they work to ensure that quality and authenticity are valued above all else.

Among other activities, the consortium works in the:

• Development of voluntary standards for the quality and authenticity of supplies and suppliers,
• Development and implementation of audit standards and auditor training and certification regarding the quality and authenticity of supplies and suppliers,
• Joint audits of suppliers to reduce audit fatigue for both manufacturers and suppliers, and
• Joint development of technologies to enhance the quality and authenticity of supplies.

LSC: What are some of the important learnings from the consortium’s work over the past eight years?

Mills: The pharmaceutical supply chain is growing all the time. With constantly evolving expectations from industry, regulators, and patients, the availability of safe, effective drugs requires manufacturers to understand and control their supply chain to a higher degree than in the past.

LSC: How do Rx-360’s joint audits work?

Mills: The Rx-360 joint audit program performs cosponsored audits of suppliers, thereby reducing the burden on suppliers in hosting multiple audits, and on manufacturer’s in fulfilling requirements for supplier management.

The more co-sponsors for a particular audit, the fewer audits the supplier has to host, and the fewer audits the manufacturers have to perform. And the cost of the audit per sponsor is reduced, depending on the number of cosponsors.

The audit reports are then made available for licensing (at the approval of the audited supplier) to Rx-360 members and non-members alike. The licensing fees are applied as credits back to the original audit sponsors, to be used towards their future Rx-360 audits.

The audit program performs audits all around the world and has controlled templates and forms to ensure a standardized approach to auditing and reporting.

LSC: What do you think are the biggest supply chain challenges facing the industry today?

Mills: There are two big challenges.

Manufacturers and suppliers are in a constant battle to ensure that the materials in their supply chain are authentic and are of the appropriate quality. Manufacturers and suppliers source materials for their production and have an equally important responsibility to understand their supply chains — and to ensure that their supply chain partners are not cutting corners or are using materials that could lead to a health crisis in the patient population.

The second challenge is the control of supply chains that are becoming more global in reach. New suppliers from around the world are being added to the pharmaceutical supply chain every year. With this growth comes the challenge of qualifying suppliers and ensuring that regional regulations are sufficient for the use of supplier materials in pharmaceutical manufacturing.

LSC: How is the consortium addressing these challenges?

Mills: Rx-360 is made up of manufacturers and suppliers that are passionate about ensuring safe supply chains and materials. The organization has numerous working groups, made up of volunteers from member companies, which address these issues in numerous ways. For example, these groups provide information on supply chain incidents, develop white papers addressing important challenges, work to understand evolving regulations, and provide auditing services to help alleviate audit fatigue and to meet requirements.

LSC: Have there been any noteworthy recent developments at Rx-360?

Mills: In 2016, Rx-360 hired its first full-time employee, Mark Paxton, to be CEO. Mark’s role is to manage the consortium and ensure that it is working on the most impactful issues facing the industry. With this focus, Rx-360 has increased its scope and reach, bringing in more members and organizations, all working to address the critical issues.

LSC: What’s next for Rx-360 under Mark’s leadership?

Mills: Rx-360’s focus continues to be in spreading the word about our activities and in creating greater awareness of the work in which it is involved. Mark recently indicated that the consortium’s top priorities are:

• Improving the speed and efficiency of the audit program,
• Addressing the highest-risk supply chain threat areas through sharing of best practices among industry and regulatory authorities, including development of enhanced training programs, and
• Developing and expressing greater use of external communications platforms for both members and non-members

LSC: How can readers obtain more information about Rx-360 — and get involved?

For starters, I would recommend they visit the Rx-360 website for more information on the consortium: http://rx-360.org/.

It is imperative that the organization continues to expand in order to address the growing list of challenges facing the industry.  Rx-360 truly is a working organization that is committed to improving the health of patients worldwide, and the more companies that are involved, the better and faster Rx-360 can be in improving the lives of millions of people.

About Ben Mills

Ben Mills is the pharmaceutical technical lead for BSI, where he manages clients’ supplier audit programs and serves as a GMP consultant to the pharmaceutical industry. Ben has more than 23 years’ experience in the biopharmaceutical quality arena. His experience includes quality systems, supplier management, quality process improvement, GMP/GDP auditing, executive facilitation/training, and contractor management. Ben is the former co-chair of the Rx-360 Audits Operations Group.