Quality system audits (QSAs) are critical for ensuring that apheresis and cell collection sites meet quality regulatory requirements as you work toward gaining FDA approval of your cell or gene therapy. But building the internal capabilities to conduct these specialized audits requires a significant investment of both time and money.
The Be The Match BioTherapies® Quality System Audit Program (QSAP) can help you:
- Simplify your cell therapy quality system audit process
- Ensure quality compliance across your collection network
- Activate your collection sites faster to bring your therapy to patients sooner
We take care of the quality system audits so you can keep your focus on developing and delivering new cell and gene therapies for patients.
Simplify your quality system audit process
If you conduct your own quality system audits, just one audit at one apheresis site can take weeks, likely months, from audit scheduling through follow-up corrective actions.
Through QSAP, you can license the QSA results for multiple apheresis sites at once from Be The Match BioTherapies.
Our experienced auditors – who are certified by the American Society for Quality – conduct quality system audits at apheresis sites to measure compliance with 21 CFR Part 1271 Good Tissue Practices (GTP) and other quality-related standards.
When you license audit results through QSAP you receive all required documentation, including:
- On-site audit checklist, notes and supporting documentation
- Audit report
- Audit findings response
- Audit closure letter
Our comprehensive QSAs meet FDA regulatory requirements for therapies in clinical trials and commercially available.
We offer this high-quality product at a significantly lower price than an independently commissioned audit.
Ensure quality compliance
During the one to two day onsite visit, our auditors follow the cell and gene therapy product journey from the point of collection to the point the product leaves the building.
Our on-site quality system audit method includes:
- Use of comprehensive checklist to evaluate regulatory compliance
- 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
Because the FDA has not yet defined quality requirements for cell and gene therapy collections, our quality system audits measure 21 CFR Part 211 Good Manufacturing Practices (GMP) along with GTP. We audit to GMP only as applicable to apheresis sites and cell therapy laboratories.
The audit report with findings is submitted to the site 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
- Recommendations for improvement
- Information on the site’s best practices
Our team works with the site to address audit findings and close the QSA once all corrective actions for critical findings are approved.
We audit apheresis sites on a two-year, rolling cycle, with surveillance audits as needed. As a cell and gene therapy developer, this provides you with a cost-effective way to ensure quality compliance across your custom apheresis site network, while minimizing the audit burden on the centers themselves.
And you can feel assured each site is providing high-quality starting material.
Activate your collection sites faster
When you license audit results through our Quality System Audit Program, you can efficiently move sites from qualification to activation because the audit is already complete.
In addition, we have contractual relationships with 112 U.S. cell collection centers through our parent company, the National Marrow Donor Program®/Be The Match®. These relationships, developed over the last 30 years, provide both audit scheduling efficiencies and a high level of confidence and familiarity with our audit process.
Be The Match BioTherapies also conducts quality system audits in Canada and Mexico, and contracts with certified partners to perform audits in the rest of the world.
We do the auditing work. You license the results. And with the quality system audit already complete, your therapy gets to patients sooner.