Case study

Maintaining the quality and surety of supply for the patient using the
Rx-360 Joint Audit Program®

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

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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.

Cell & Gene Therapy

Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working toward resolving the current challenges to commercializing C&GT products. Discover more and learn about the outputs here.

Development Group

The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

Drug Substance

Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives

Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.

Find out more about what our members are currently discussing and learn about some of the successful implementations of our output.

Fill Finish

Quality and demonstrating compliance are two priorities of BioPhorum Fill Finish. Representatives of the world’s top sterile filling operations come together to develop solutions to some of the most intractable technical and regulatory challenges.To address these challenges in drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations, our community of industry experts is working relentlessly to continually improve the pharmaceutical quality system (PQS). Together they continue to strive towards developing and implementing safe, predictable, lean, and agile processes in drug product operations. Find out more about the Phorum output here. 

Information Technology

IT and digital advances are crucial in responding to the pharmaceutical industry’s challenges around speed, cost, quality, flexibility, and sustainability. Unlocking and realizing the value in the industry’s IT opportunities is the core mission of the IT Phorum. 

The digital manufacturing facility of the future needs to consider technology advances alongside organizational perspectives while maintaining foundational security requirements. All elements must be considered in the long term to deliver systemic change toward the digital factory vision. Our members collaborate in a format that stimulates and supports industry innovation and implementation. 

Regulatory-CMC

BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, filing and review, interactions with Health Authorities, and harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.

Supply Chain to Patient

The pharmaceutical outbound supply chain was built on a blockbuster model and doesn’t fit the needs of the changing pipeline and new modalities currently being developed. The geopolitical challenges of recent years have shown that the outbound supply chain needs to evolve to become more agile, and resilient, and address a more expectant end-user bying on patient-centricity. Industry collaboration can accelerate improvements and transform performance in a way not possible when working independently. This Phorum is founded on the belief that learning from each other and challenging current thinking to re-imagine the supply chain can reduce costs and increase efficiency.

Supply Partner

BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:

  • an enhanced robustness and resilience
  • accelerated capability and capacity to effect technology adoption
  • reduced cost of quality, and
  • industry-wide alignment on operational implementation

There’s an extensive list of Phorum successes and tangible benefits that have been delivered to define industry best practise.

Sustainability

The BioPhorum Sustainability program is jointly designed, governed, and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership means that we can quickly focus on the areas that have the greatest industry impact, and we can leverage learning from each other and other sectors – the chemical industry and the built environment for example.

BioPhorum’s unique ability to build a strong coalition for change for an entire industry is now being applied to the greatest challenge of our generation. Driven by evident industry needs, Phorum members are working to develop agreed industry benchmarks, establish the ROI of sustainability investments and to increase the efficacy of implementation of members’ sustainability strategies.

Technology Strategy

With a mission to define strategies to accelerate technology transformation and support the adoption of innovative technologies, BioPhorum Technology Strategy evolved from BioPhorum Technology Roadmapping, strives to realize the technology roadmap vision 2.0.

This is being achieved through a multi-stakeholder team of member companies with collective capability and influence who are committed to driving forth industry goals associated with: Speed to market, Quality, Value, Agility and On-Demand Supply and Sustainability.

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Electronic data exchange – the foundation for an efficient, resilient inbound supply chain

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How are you improving your environmental sustainability performance?

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Introducing MediPhorum

The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

Advanced Wound Care and Wound Management

Advanced wound care (AWC) is the medical treatment for wounds that have not healed properly using conventional wound care products such as gauze, bandages, plasters, and wadding.

AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

Drug Delivery

Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more
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