Ensuring regulatory compliance of your cell collection centers and cell therapy labs is a critical step toward FDA approval of your therapy. Building the infrastructure to audit each site and train highly-specialized auditors is both time-consuming and costly.
Through our Quality System Audit Program, Be The Match BioTherapies® offers cell and gene therapy companies the ability to license our cell collection center and cell therapy lab quality system audit results, evaluating compliance with both 21 CFR Part 1271 Good Tissue Practice (GTP) and 21 CFR Part 211 Good Manufacturing Practice (GMP) regulations.
Be The Match BioTherapies’ auditors are certified by the American Society for Quality, with more than 40 years of combined specialized experience in auditing for collection centers and cell therapy labs for compliance to GTP, GMP and other quality related requirements. Cell collection centers and cell therapy labs are audited on a two-year, rolling cycle, with surveillance audits as needed to provide cell and gene therapy developers a cost-effective way to ensure up-to-date quality compliance across broad collection center networks, while minimizing the audit burden on the centers themselves.
By leveraging our licensed audit results, companies receive:
- On-site audit checklist, including notes and supporting documentation reviewed
- Audit report
- Audit findings response
- Audit closure letter
- High-quality product at a significantly lower price than an independently commissioned audit
Industry-leading experience in cell collection center qualification
Through our parent company, the National Marrow Donor Program®/Be The Match®, we have contractual
relationships with more than 112 U.S. cell collection centers. These relationships, developed throughout the last 30 years, provide both audit scheduling efficiencies and a high level of confidence and familiarity with our audit process.
In addition to current audits of U.S. cell collection centers, Be The Match BioTherapies conducts audits in Canada and Mexico, and contracts with certified partners to perform audits in the rest of the world.
On-site audit method includes:
- Use of comprehensive checklist to evaluate regulatory compliance to GTP and GMP requirements
- 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, storage, cryopreservation and transport; tracking and traceability; personnel training; deviations, CAPA, complaints and adverse events; and document/record management system
Additional information provided:
Audit report with findings (Submitted to center within two weeks of audit)
- Provides summary of audit method, documents reviewed, executed/in progress changes and future planned changes, and listing of audit findings
- Rates audit findings as minor, major or critical
- Includes recommendations for improvement and information on center best practices
- Work with center to address audit findings
- Close audit when corrective actions are approved
- Send closure letter to center