Quality system audits (QSAs) of the apheresis centers that will collect for your autologous therapy are critical. You must know the centers have robust quality systems to meet regulatory requirements for FDA approval.
But conducting the audits yourself takes significant time, resources and money. And while center accreditations are beneficial, you can’t rely on them alone to gauge the health of a center’s quality system.
Our Quality System Audit Program (QSAP) allows you to efficiently move centers from qualification to activation. We do the auditing work. You license the results. And with the quality system audit already complete, your autologous therapy gets to patients sooner.
How the Quality System Audit Program saves you time
If you conduct your own quality system audits, just one audit at one apheresis center can take weeks—likely months—from audit scheduling through follow-up corrective actions.
QSAP provides an opportunity to license QSA results for multiple U.S. apheresis centers at once from Be The Match BioTherapies®.
We built QSAP using the auditing expertise developed to support allogeneic collections. We conduct quality system audits of all the apheresis centers that collect for our Cell Sourcing service.
Quality System Audit Program Deliverables
When you license audit results through QSAP you receive:
Draft audit report, if still in progress
Corrective action response
Final audit report, including closed corrective actions with implementation evidence, to be used for regulatory filings
Rely on a team with relationships and experience auditing apheresis centers
QSAP audits provide a comprehensive view of the health of the quality system at an apheresis center. They are not product specific.
Our experienced, highly qualified auditors measure compliance with:
- 21 CFR Part 1271 Good Tissue Practices (GTP)
- 21 CFR Part 211 Good Manufacturing Practices (GMP)
We audit to GMP as applicable to apheresis centers and cell therapy laboratories.
QSAP audits are intended save you the time and money necessary to audit each center. At the same time, they reduce the burden of multiple audits on apheresis staff.
In addition to auditing apheresis centers in the U.S., we conduct quality system audits in Canada. We contract with certified partners to perform audits in the rest of the world.
A QSAP audit is focused specifically on quality systems versus assessing a center for the capabilities required to support a specific therapy. If you need a center capabilities assessment, we conduct these assessments as part of our Collection Network Development service.
Have questions about licensing quality system audit results?
Let’s talk about how you can activate your cell collection centers faster.
How we audit apheresis centers
During the one- to two-day audit, our auditors follow the cell and gene therapy product journey from the point of collection to the point the product leaves the building.
Our quality system audit method includes:
- Interviews with staff and review of documentation, such as SOPs, policies and quality plans
- Evaluation of multiple systems and functional areas, including:
- Collection process
- Product labeling
- Cryopreservation and transport
- Tracking and traceability
- Personnel training
- Deviations, CAPA, complaints and adverse events
- Document/record management system
- Center audits on a two-year, rolling cycle, with surveillance audits as needed
The audit report with findings is submitted to the center within 30 days of the audit. The audit report provides a summary of:
- Audit method
- Documents reviewed
- Executed/in-progress changes and future planned changes
- Listing of audit findings, with ratings of minor, major or critical
Our team works with the center to address audit findings and close the QSA once all corrective actions for critical findings are approved.
As a cell and gene therapy developer, this provides you with a cost-effective way to ensure quality compliance across your custom apheresis network, while minimizing the audit burden on the centers themselves.
Conducting QSAs during COVID-19
We have developed a virtual QSA process using web-based technology to conduct audits during the COVID-19 pandemic.
We use this process for apheresis centers and labs that have not yet been audited as part of QSAP. This allows you to continue to move your therapy forward when an on-site audit is not possible.
Have questions about how we conduct quality system audits?
We’d love to discuss the process with you.
Access additional services from Be The Match BioTherapies
Allogeneic Cell Sourcing
Reliable sourcing of high-quality donors with collection and delivery scheduling and oversight.
Supply Chain Management
End-to-end autologous supply chain coordination and oversight from collection to therapy delivery.
Frequently asked questions
What is the difference between the QSAP audit from Be The Match BioTherapies and a FACT or AABB accreditation?
FACT and AABB accreditation are excellent systems to ensure that a quality system has been put in place at a collection center. However, the accreditation process does not look in depth at the health of the quality system. Our QSAP audit is designed to work in harmony with FACT or AABB accreditation and fill in the gaps to gauge the health of the quality system.
Does an apheresis center get to decide if my company can license their audit results?
We contact the apheresis center for approval prior to licensing a QSAP audit to a cell therapy developer.
Are audits product-specific? How can I ensure that a Be The Match BioTherapies audit will cover all the items I am interested in?
QSAP audits are not product-specific. The QSAP audits provide a comprehensive view of the health of the quality system at an apheresis center. This program is designed to reduce the burden of multiple audits on apheresis center staff.
It is part of the center qualification process but does not replace it. You will have visibility into the scope of the QSAP audit. We can work with you to address any gaps that may arise.
Can you conduct quality system audits remotely during COVID-19?
Yes. Our Be The Match BioTherapies team has developed a program that allows us to conduct audits in a virtual environment. Most apheresis centers are able to support remote audits.
Why do you audit to GMP when apheresis centers are not manufacturing locations?
Although apheresis centers are not manufacturing products, they are isolating the most critical input material for the manufacturing process. We feel it is critical to ensure this material is collected, labeled and tracked under a robust quality system.