Quality System Audit Program

Accelerate patient access to new cell and gene therapies through the Quality System Audit Program

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Spend more time with patients, less time on audits

If you aren’t already feeling the audit burden due to the rise in demand for cell and gene therapies, you most likely will soon. This rapid increase means repetitive quality system audits (QSAs) at your apheresis site—taking valuable time and resources from apheresis site staff.

You know it’s required by the Food and Drug Administration (FDA), but there has to be a better, more efficient way for patients to get access to new cell and gene therapies and for your apheresis or collection center to spend less time on audits.

Be The Match BioTherapies® has your solution: our Quality System Audit Program (QSAP).

Our QSAP is designed to help you bring new cell and gene therapies to patients sooner, while helping you take back time for your staff so you can spend more time with patients, and less time with auditors.

Take back your time with QSAP.

With the Quality System Audit Program, there’s no need for your site to undergo individual, yet similar, quality system audits by multiple cell and gene therapy companies. This helps your site more efficiently provide high-quality, consistent cellular starting material, and at the same time, avoid the inefficiencies of redundant audits with overlapping findings and conflicting corrective actions.

Instead of undergoing multiple audits from multiple cell and gene therapy companies, one of our experienced auditors, certified by the American Society for Quality, will audit your center for compliance with 21 CFR Part 1271 Good Tissue Practice (GTP) and other FDA regulations and quality requirements for cell and gene therapies.

Time on Audit Activities

Results from September 2018 Be The Match BioTherapies survey of NMDP/Be The Match apheresis and marrow collection centers.

Limit the number of audits at your center every year with QSAP.

Multiple cell and gene therapy companies can license your quality system audit results from Be The Match BioTherapies, because our audits are not therapy-specific and can satisfy FDA requirements for both clinical trials and commercial therapies.

When your organization participates in QSAP, it means that when the next company asks to audit your site, you can request that they obtain your quality system audit results from Be The Match BioTherapies instead.

Reduce your site qualification time with QSAP.

Sometimes your patients don’t have time to wait. They need access to the latest treatment options, and they need it as soon as possible. The Quality System Audit Program can reduce the amount of time required for site qualification for each new therapy because your quality system audit is already complete.

Our QSA is designed to encompass not just the therapies your organization will offer patients today, but those you may offer in the future. So you can accelerate your patients’ access to new cell and gene therapies, and scale with therapy developers as their therapies transition from clinical development to commercial delivery.

How does the Quality System Audit Program work?

Our QSAs measure compliance with GTP, Good Manufacturing Practice (GMP) and other common quality requirements for cell and gene therapies.

 

Because the FDA has not yet defined quality requirements for cell and gene therapy collections, our quality system audits measure both GTP and GMP. Not every aspect of GMP applies to apheresis or collection sites and cell therapy laboratories; we audit to GMP only as applicable for apheresis or collection sites and cell therapy laboratories.

 

There’s no cost to your center to participate in QSAP. It just requires a signed agreement.

 

Here’s what you can expect:

  • One-to-two day onsite audit visit, which follows the apheresis product journey from the point of collection to the point the product leaves your site.
  • Prior to our auditor’s onsite visit, we’ll request documents to review, such as SOPs, and provide your team with a pre-audit checklist for preparation.
  • Following the onsite audit, your organization will receive an audit report with findings and a Supplier Corrective Action Request (SCAR) for each finding.
  • We’ll audit your center every two to three years, which provides you with long-term audit consistency and predictability.

After the quality system audit is closed, cell and gene therapy companies can license your audit results through QSAP. They will receive:

  • On-site audit checklist
  • Audit report
  • Audit findings response
  • Audit closure letter

You can determine which cell and gene therapy companies can access your results. More than a dozen cell and gene therapy companies are currently using QSAP and that number continues to grow as more therapies enter clinical trials and near commercialization.

 

Currently contracted National Marrow Donor Program® (NMDP)/Be The Match® Network centers can also participate in QSAP.

 

If your center is part of the NMDP/Be The Match Network, being part of our Quality System Audit Program does not require an additional audit at your center by Be The Match BioTherapies. Cell and gene therapy companies can license the results of the quality system audit the NMDP/Be The Match performed as part of your participation in the Network.

 

Our goal is to support the apheresis industry in providing high-quality, consistent cellular starting material for therapies, while also eliminating redundant audits and reducing the amount of time required for site qualification so your center can provide new cell and gene therapies to patients sooner.

How is QSAP different from an accreditation inspection?

A quality system audit for QSAP does not replace an accreditation inspection for an organization such as FACT or AABB and vice versa. Both are important to ensure patients receive a high-quality cell or gene therapy.

 

Quality system audits measure compliance with FDA regulations such as GTP and GMP. For cell and gene therapies, the FDA currently requires an audit of the critical supply chain. Our QSAP meets this FDA requirement, while also alleviating the necessity for multiple audits at cell collection sites and cell therapy labs.

 

The work of accrediting agencies is very important in ensuring sites have clinical competency and receive payment for therapies provided. Accreditation inspections review for compliance to the accrediting body’s standards and many payers require accreditation for reimbursement.

Get started with QSAP.

As more cell and gene therapies enter clinical trials and receive FDA approval, more companies will require a quality system audit. Being part of our Quality System Audit Program streamlines the number of audits at your center every year.

And the best part? With your QSA already done, you can bring new therapies to patients sooner.

Contact us and start changing the way you do business.


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