Any establishment that performs any step in the manufacture of human cells, tissues, and cellular/tissue-based products (HCT/Ps) must establish and maintain a quality program appropriate for the manufacturing steps performed and the specific HCT/Ps manufactured §1271.160(a).

Inspected by the FDA every two years, the Eye Bank and Assisted Reproductive Technology Program/ART programs have passed their FDA inspections with No Action Indicated since December 2005. The Eye Bank is also accredited by the Eye Bank Association of America (EBAA) and inspected every 3 years. A 3-year accreditation was confirmed in June 2019.

Quality control activities include:

  • Maintenance of Eye Bank and ART Program policies/SOP’s to ensure compliance with federal regulations and EBAA Medical Standards
  • Investigation and reporting on adverse reactions, deviations and recalls to the FDA and EBAA
  • Addressing corrective actions relating to core cGTP requirements (e.g., re-audits of deficiencies and documentation). Tracking corrective actions so that actions are effective, sustaining, and prevent recurrence.
  • Conducting monthly reviews of all donor and environmental monitoring records for the Eye Bank and the ART Program
  • An annual comprehensive quality audit for both Eye Bank and the ART Program are performed
  • Annual environmental viable particulates monitoring in the processing room and bi-annually in the Walk-In Clean Room and BSC for the Eye Bank
  • Process validation (Laboratory Corneal Excision, Scleral Preservation, Long Term Storage, DSEAK and DMEK procedures)
  • Qualification of new purchased equipment and certification/calibration of existing equipment
  • Periodic audits of establishments under contract or other agreements for manufacturing steps for the establishment (testing laboratories, donor screening, sterilization services, etc.)
  • Ensure personnel in activities related to core cGTP requirements have proper training/education to perform their activities