The landscape
BioPhorum Supply Partner (SPP) collaborated with Rx-360 in 2019 and 2020 to raise awareness of the value of using the Rx-360 Joint Audit Program® to help alleviate the audit burden in the in-bound supply chain. The collaboration focused on the single use systems supply base where awareness was low within SPP members. The approach adopted was to create a pilot program that was completed in 2020 after conducting eight on-site audits of SPP members’ facilities.
This case study discusses a qualification audit of a new facility expansion at CPC, a tier 2 supplier of single use connections for bioprocessing. CPC opened an extended and redundant production facility and global headquarters in June 2020 in Roseville, Minnesota, US. The new facility contains an ISO Class 7 cleanroom, collaborative R&D, new product development and laboratory spaces to support and accelerate innovation. The audit was co-sponsored by three major biomanufacturers
The value of using the Rx-360 Joint Audit Program® – qualifying a supplier’s new production facility: a case study
The challenge
The need for a qualification audit of the new production facilities was required before the Covid-19 pandemic happened. As a member of the SPP, CPC was aware of the value of using an Rx-360 Joint Audit Program® and intended to use it to qualify its new facility. Covid-19 travel and safety restrictions meant that this need was amplified, as facilitating a qualifying audit without using the Rx-360 Joint Audit Program® approach would not be operationally possible as the facility needed to be protected from Covid-19. CPC’s capacity was also urgently needed to meet the dramatically increased demand for the single use connectors used to combat the pandemic. Any delays in the supply chain would ultimately affect patient care – the Rx-360 Joint Audit Program® approach would help facilitate the facility’s rapid qualification.
This program would not have been a success if it wasn’t for the audit sponsors. Their involvement allows them to even recoup their audit expenses through the Rx-360 Credit Program.John Boehm, Vice President Biopharma at CPC
The value of the Rx-360 Joint Audit Program®
CPC used the Rx-360 Joint Audit Program® to create a single audit report of its facility that can be licensed for use by different customers when qualifying the facility. This approach significantly removes the audit burden for both suppliers and manufacturers. While the SPP collaborated with Rx-360 on a pilot program to raise awareness of the value of the Rx-360 Joint Audit Program® model, the team is keen to point out that the benefits of this approach extend beyond the single use systems supplier base to include all in-bound raw materials, consumables and service providers. It is a real asset for accelerating the availability of materials for industry during this stage of the pandemic, where travel and access to facilities are limited. To conduct audits of existing and new facilities in this fast and efficient way, and for the reports to be accessible without conducting individual audits, is a real bonus and avoids creating an audit burden that slows down the industry.The outcomes
In August 2020, CPC had its first and only on-site audit of the new production facility, and the auditor was the first non-CPC employee allowed on-site since Covid-19 restrictions had been applied. The Rx-360 Joint Audit Program® approach enabled a longer audit in a Covid-19-secure way of working, ensuring an effective audit report. This minimized any potential impact on the supply chain and ensured that CPC’s connectors could be produced and distributed as soon as possible, accelerating material availability by several months. As of October 2021, the audit report has been licensed by 14 companies. Rx-360 said that the high number of licenses meant the CPC program was one of the most successful audits it had seen in the first six months of an audit report’s publication. The audit report, which can be licensed for a fee, received the full audit documentation package that contained the audit plan, the auditor’s qualifications and the final report. Licensees can also see any corrective and preventive actions (CAPAs) which has been stated as a real benefit. Covid-19 restrictions are helping to drive customer acceptance of the Rx-360 Joint Audit Program®, with the US’s Operation Warp Speed (which accelerated the testing, supply, development and distribution of safe and effective Covid-19 vaccines, therapeutics and diagnostics) and vaccine production demand also increasing the rate of acceptance. Even though Covid-19 restrictions are lessening, the joint audit approach is still a vital tool in assisting with the availability of materials from new facilities and line expansions and the Pilot Program continues to be influential in driving customer acceptance of programs like the Rx-360 Joint Audit Program®.While they footed the upfront bill for the audit program, the sponsors get their audit fees back as people license the program. Ultimately, it doesn’t cost them a dime.John Boehm, Vice President Biopharma at CPC
Lessons learned
CPC’s awareness of the Pilot Program collaboration between the SPP and the Rx-360 Joint Audit Program® team helped its internal pre-audit planning. The audit surveys and pre-meetings with Rx-360 were also invaluable, particularly considering Covid-19 restrictions. These early actions were vital to educate and build an understanding of the Rx-360 Joint Audit Program® across CPC employees.
However, there is a need for more people to know about the Rx-360 Joint Audit Program®. Even some of the companies that took part in the collaboration to raise awareness may not fully understand its robustness and how it is part of an appropriate risk-based program. It is not just for biomanufacturers to audit their tier 1 suppliers, but also for each tier to audit their own suppliers, and so on down the supply chains. Raising awareness of the Rx-360 Joint Audit Program® will be crucial to manufacturers and their suppliers at all tiers for their future success.
Conclusion
Covid-19 restrictions meant CPC could not take the risk of allowing multiple customer audits of its new facility. Without the Rx-360 Joint Audit Program®, CPC could not have arranged for its facility to be qualified until travel and safety restrictions are eased. Therefore, it could not have addressed the Covid-19 demand spike that came from supporting Operation Warp Speed or the non-Covid-19 customers who needed single use connectors. “As an industry, we have an incredible tool in the Rx-360 Joint Audit Program® that can help get new capacities approved and accepted faster; it was vital in getting our redundant manufacturing facility up and running in time to meet the increased demand of the market” said John Boehm, Vice President Biopharma at CPC. “We know that other integrators are adding capacity and they need help getting these approved to continue to meet market demands. The Joint Audit Program® will help them do this.” Boehm added, “With the heavy lifting done by Rx-360 over the years to develop and drive this model, coupled with the participation of BioPhorum members during the collaborative pilot program on single use systems, we have an opportunity to build on this program, increase awareness and education, and break down the barriers to its acceptance. Even as Covid-19 restrictions lessen, this is still an incredible tool to quickly facilitate audits as we all expand capacity to meet the unprecedented demand we are seeing.” CPC’s use of the Rx-360 Joint Audit Program® not only sped up the qualification of its new facility and kept people safe during the pandemic, but had a positive impact on the supply chain and patient care.Rx-360
Rx-360, a non-profit international pharmaceutical supply chain consortium, formed in 2009 to support an industry-wide commitment to ensuring patient safety by enhancing quality and authenticity throughout the supply chain. To fulfill this mission, Rx-360 has developed and grown a unique Audit Program to assist the industry in maintaining patient safety and material quality.
To learn more about Rx-360, please visit http://www.Rx-360.org or email jfries@rx-360.org
About BioPhorum
BioPhorum is a company-to-company collaboration. Its mission is to create an environment where the global biopharmaceutical industry can collaborate and accelerate its rate of progress, for the benefit of all.
Formed in 2004, BioPhorum now comprises more than 100 manufacturers and suppliers deploying their top 5,000 leaders and subject matter experts to work in nine focused Phorums, articulating the industry’s technology roadmap, defining the supply partner practices of the future, and developing and adopting best practices in drug substance, fill finish, process development, manufacturing IT, cell & gene therapy and medical technology.
