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.
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 outcomeSartorius 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.
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.”
- 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.
- 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
- 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
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.
BioPhorum deliverables and guidance
At BioPhorum.com you can find a host of single use system-related deliverables and guidance to support adoption of industry best practice including:
Single use system audit guide
Change Notification: A guide to change notification packages for single-use manufacturing systems
Single-use, change notification: A guide to the classification of changes to SU manufacturing systems
Single Use User Requirements Specification Toolkit
Disposables: Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing
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.