Case study

Implementing the Joint Audit Approach at Sartorius Bioprocess

The context

As a member of BioPhorum, Sartorius participated in the BioPhorum Supply Partner pilot program initiated with Rx-360 to raise awareness of the utility of a Joint Audit Approach in the Single Use Systems supplier community (click here for more information).

Sartorius’ participation, and the successful pilot detailed here, gave them the confidence to integrate the approach to support capacity increase with an agile site qualification service for customers.

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The story

At Sartorius Bioprocess, the single-use network capacity expansion revealed the need to implement a joint audit approach across all sites in the biopharmaceutical network to enable fast site qualifications by customers. In 2019, the audit capacity of some sites became a bottleneck with a lead time of more than six months, despite offering two audits per week.

Sartorius, as a user of Rx-360 Joint Audit Program® and board member of their consortium, developed a strategy to improve audit capacity and create a fast site qualification service that included the implementation of a full-system qualification with routine re-qualification every two years.

To enable global standardization, a pilot was run during 2019/20 focused on single-use manufacturing with several sites. This was planned for extension from 2021/22 to include systems manufacturing, media manufacturing, and distribution centers. For sites with more than one business area, an audit was conducted and reported per area.

This strategy led to some challenges, such as the need for increased communication to customers about our decision to take this approach (including close tracking), the efforts needed to increase customer sponsoring, and the improvement in the conversion rate/lead time of potential licensors. An additional challenge was the need to focus on the audit planning forecast and resources. This included the anticipation of needs, management of interfaces and the iteration loops required for the most stringent and accurate planning (including the anticipation of new site ramp-ups and the impact of this).

I believe the pilot helped Sartorius to understand the added value of the model at a higher level.

Jim Fries, CEO Rx-360

The outcome

Sartorius has moved toward audit delegation to optimize global audit capacity and provide fast access to a standardized site qualification package to all customers. Joint audits are strengthening Sartorius’ supply chain delivery reliability through an agile site qualification program. Adopting a global joint audit approach supports standardization and continuous improvement at Sartorius’ Bioprocess Division. It is a pillar in supply chain resilience, and it serves the Customer Quality Experience program with developing quality services to customers for delivery reliability. Hence, Sartorius has fully integrated the Rx-360 Joint Audit Program® in its QMS – change management and quality service to customers. Sartorius provides, communicates and continuously improves the site qualification service to customers with packages in three levels of service.

The benefits

Introducing the joint audit approach has resulted in many benefits, and Jim Fries, CEO Rx-360 commented, “I believe the pilot helped Sartorius to understand the added value of the model at a higher level.”

Vanessa Nardolillo, Head of Quality Management and Regulatory Affairs Division Bio Process Solutions at Sartorius said, “Being a member of Rx-360 and participating in BioPhorum enabled us to learn about the utility of a Joint Audit approach through the Pilot Program, and that gave us the confidence to develop a site qualification program in different service levels for the benefit of our customers and for agility in supply chain management.”

Benefits included:

Quality

    • Sponsoring customers can influence the audit agenda/checklist
    • Consistency with the documentary qualification package – Rx-360 Supplier Assessment Questionnaire (SAQ) package
    • Third-party audit by independent auditor – considered at Sartorius like a certification auditor
    • Audit referentials adapted to the industry (e.g., single-use) and influenced by co-sponsors
    • Site equivalency assessment maintained for customers
    • Continuous improvement of a global quality system, global CAPA, lessons learned and best practices.

Lead time

    • Customer fast track site qualification or minimum pre-qualification
    • Fast report availability for licensing: 2–3 weeks when the report is released
    • Agile site qualification in capacity expansion: Sartorius pilot target audits

Cost

    • Audit capacity optimization for customers and suppliers – resource availability
“Being a member of Rx-360 and participating in BioPhorum enabled us to learn about the utility of a Joint Audit approach through the Pilot Program, and that gave us the confidence to develop a site qualification program in different service levels for the benefit of our customers and for agility in supply chain management.”

Vanessa Nardolillo, Head of Quality Management and Regulatory Affairs Division

Lessons learned

Key elements for a successful adoption include close internal and external communication with a dedicated team for managing the program – from planning to CAPA surveillance. Sharing the lessons learned at the global quality level is the final step.

Rx-360

Rx-360, non-profit, is an 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. The organization’s mission is to protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of its materials primarily through its working group and unique audit program.

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.

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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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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

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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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