Ensuring regulatory compliance of your cell collection centers is a critical step toward FDA approval of your therapy. Building the infrastructure to audit each center 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 reports, evaluating compliance with both Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) regulations.
Be The Match BioTherapies’ auditors are certified by the American Society for Quality, with more than 40 years of specialized experience in auditing for collection centers and cell therapy labs for compliance to 21 CFR Part 211 GMP and 21 CFR Part 1271 GTP and other quality related requirements. Collection centers and cellular therapy labs are audited on a two-year, rolling cycle 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 reports, companies receive:
- On-site audit checklist, including notes and supporting documentation reviewed
- Audit report
- Audit closure letter
- High-quality product at significantly lower price than an independently commissioned audit
Industry-leading experience in 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. apheresis 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 GMP and GTP 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
- On site re-audit every two years
- Surveillance audits as needed
Additional deliverables provided to clients:
Audit report with findings (Submitted to center within two weeks of audit)
- Provides summary of audit method, documents reviewed, summary of executed/in process 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