By Tony Khoury, Austin Potthoff, and Danny Foody, Project Farma
Factory acceptance testing (FAT) is a critical process that relies on strong relationships between a life science manufacturer and its equipment vendor, as well as suitable technology and infrastructure. A smooth and successful FAT is often vital to the client’s production timeline. The FAT is performed at the vendor facility and upon successful results, the system is shipped to the client’s site. The outcomes of these tests will help verify that the system meets the design and functional specifications outlined by the client’s project teams, as well as provide an opportunity to make corrections or adjustments prior to shipping the system to the client’s facility. The current best practice for performing FAT is to apply a risked-based approach to identify and then verify critical functions of the system; this methodology assures quality by design principles to leverage testing safely and efficiently.
Traditionally, FATs are performed in person and on-site so the client and vendor teams can properly assess all functional, design, and user requirement specifications. Since the COVID-19 pandemic has limited travel and on-site personnel, the life science manufacturing industry has been challenged to adapt. Postponing activities until travel restrictions are lifted could put project timelines at risk, potentially delaying the delivery of treatment to patients. These unprecedented times have required the industry to pivot and find new solutions and methods of carrying out quality and safety testing.
Performing virtual FATs (vFATs) can be a helpful solution in these new and uncertain times, though it does come with added risk. Without having the team on-site, remote FATs present a higher possibility for equipment to be shipped without meeting the end user’s requirements and functional specifications.
Whether the assessments are being performed in person or virtually, the goal of every FAT is to assure that the system(s) has been verified to operate as intended and that the results are well documented. Best practices should leverage an approach focused on system safety and quality to ensure the successful shipment and receipt of equipment.
We have had the opportunity to partner in a multitude of vFATs since the start of the pandemic and travel restrictions. Two cases in particular allowed for a greater understanding of the dos and don’ts of a virtual FAT.
Case Study 1: Bad Planning, Poor Communication Lead To Virtual FAT Delays
The first case study, involving a pump cart, was originally scheduled for a two-day timeline to completion. The vendor did not have video conferencing capabilities, so the vFAT commenced without real-time involvement from the client. The vendor’s team identified design gaps that required layout changes but needed client approval prior to performing these updates to the equipment. As a result, the actual vFAT execution ended up taking two weeks, and the relationship between the vendor and client was damaged.
The vFAT was unsuccessful for several reasons, including the fact that the vendor did not utilize any video conferencing capabilities, which made real-time communication segmented and inefficient. Additionally, the vendor did not include the client’s validation, system owner, or engineering lead during vFAT execution, instead choosing only to work with the automation team offline to make the required changes to pass the testing. To satisfy proof of testing, their team sent MP4 videos after the updates, which was a major factor in the delayed timeline. A clear vFAT strategy, including defined roles and schedule, was not developed ahead of time or enforced throughout testing, and the communication plan was not followed.
Case Study 2: Applying Lessons Learned To Speed The vFAT Process
In the second case, a tangential flow filtration (TFF) skid was fabricated for tech transfer in support of downstream purification. The estimated time to completion was nine business days. An established design, a detailed communication strategy, and a schedule were put in place ahead of time, and video conferencing was utilized, allowing for upward of 10 subject matter experts and FAT personnel to view vFAT execution in real time. Preparing a solid strategy led to a successful vFAT, executed in just seven days, and a vital business relationship was strengthened through the team’s proven ability to execute, even during challenging times.
Crucial to the success was ensuring that an involved FAT lead and a coordinator to support all conferencing needs were designated in advance and that all participating disciplines knew their roles and were available when needed. The equipment design was finalized prior to the start of the vFAT, and all changes were properly documented. These factors, along with coordinating video conferencing prior to the vFAT start, allowed for separate validation and engineering workstreams to complete a smooth and timely vFAT execution. In this vFAT, a detailed schedule for the cross functional teams was implemented, and multiple communication mediums and strategies for each workstream were established. The materials required for testing were identified and shipped to the vendor’s site in preparation for the vFAT.
Best Practices For Your vFATs
Transitioning to a remote process presents a number of challenges, so manage your expectations and understand that performing these assessments virtually is quite different from being on-site. The key factors to achieving success are building great working relationships, close partnering with your vendors, and implementing the tools and infrastructure to operate in a virtual setting. Leveraging your lessons learned allows you to apply them to future adaptations of the virtual FAT process.
Implementing remote control strategies helps maintain constant communication throughout and ultimately expedite vFATs. At the beginning of each day, a designated team member should set up a WebEx and Skype conference for each separate workstream — this will enable continuous communication for breakout conversations and of end-of-day briefs. Incorporate the conferences and login information into the schedule ahead of time. Additionally, automation via applications like TeamShare can establish remote control of equipment and enable direct testing and setup capabilities.
The vFAT case study reveals that following this playbook can result in reduced cost and timelines, while also providing higher participation. When properly executed, these practices could provide benefits even without the threat of a pandemic. A typical budget for an in-person FAT is $40,000, to cover travel and other expenses; if completed virtually, these funds can be funneled back into other areas of a project. The future of travel and on-site work is uncertain, so now is a perfect time to explore this new virtual method of executing FATs. The supporting technologies and techniques will continue to evolve, making vFATs even more efficient and effective in the future. The ability to adapt to any circumstance and pivot your strategy to continue providing lifesaving therapies to patients is paramount.
About the Authors:
Tony Khoury, SVP of Client Technical Services at Project Farma, is a 17+ year veteran of the biotech / pharmaceutical industry. As a member of the Project Farma leadership committee, he has spearheaded the company’s growth in the gene and cell therapy space. Khoury has extensive experience with small and large molecules including biologics, biosimilars, and gene and cell therapies. He has worked with small and large biotech and pharmaceutical companies including gene and cell therapy startups and CMOs/CROs. Khoury has led global programs of $350+ million in the following disciplines: project management, turnkey facility builds, automation, validation, engineering, and serialization track and trace.
Austin Potthoff, senior consultant at Project Farma, has extensive experience in capital project management and validation in the pharmaceutical, medical device, biotechnology, and advanced therapy industries. With Project Farma, he has led and managed validation teams of 10+ team members in project engineering, project management, and commissioning and qualification in the pharmaceutical and biopharmaceutical industry. In addition to implementing new facility build out and qualification for complex molecule manufacturing, Potthoff recently successfully managed tech transfer in existing facilities for novel processes that require significant infrastructure change.
Danny Foody, manager of Technical Operations at Project Farma, has supported and led capital projects for several partners in the advanced therapies and biologics space. He provides technical and quality leadership to start-ups and established pharmaceutical companies for CMO/CDMO operational readiness capabilities. Working with Project Farma’s Technical Operations team, he provides subject matter expertise in designing, implementing, and maintaining cGMP facilities. Prior to Project Farma, Foody worked in an analytical and quality control laboratory. He earned his B.S. degree in molecular and cellular biology from University of Illinois Urbana-Champaign.