Cell Therapy Facility

Quality Assurance

The Cell Therapy Facility (CTF) is fully supported by a robust Quality Assurance (QA) Program including:

  • Written Quality Management Plan
  • Protocol development and review
  • Training and Competency
  • Outcome analysis
  • Assessments/audits
  • Mechanisms to detect and report errors, accidents and adverse events
  • Records review and control
  • Reagent, equipment and procedure validation
  • Facility, reagent, supply and equipment qualification
  • Inventory control
  • Product tracking
  • Process control
  • Vendor qualification

Quality Control
 
Established Quality Control (QC) procedures ensure all equipment and reagents used in product collection, processing, testing, storage and distribution function as required.

Document Control Procedures

Maintain documents related to product processing, testing, storage, distribution and administration to ensure:

  • Pertinent document availability in all manufacturing locations
  • Only current version available for use
  • Standardized format for SOPs, forms and worksheets
  • Obsolete documents archived
  • Document revisions reviewed and approved by qualified personnel before implementation
  • Controlled distribution

Validation 

CTF performs extensive validation for critical procedures, reagents, supplies and equipment used in manufacturing. This assures consistency in producing predetermined results and quality characteristics. Validation plans include steps in the manufacturing process, equipment/reagents used, in-process/release testing, assessments, expected results, observed results, data, forms, charts and conclusions. 

Regulatory and Accreditation Compliance

Food and Drug Administration (FDA)

  • CTF is FDA registered (http://www.fda.gov/cber/gene.htm) to recover, screen, test, package, process, store, label and distribute human cells, tissues and cellular and tissue based products (HCT/Ps).

Foundation for Accreditation of Cellular Therapy (FACT)

  • CTF has been accredited by FACT without interruption since June 2000 (http://www.factwebsite.org) for cellular therapy product collection, processing and administration.

College of American Pathologists (CAP)

  • CTF undergoes voluntary, non-regulated accreditation as published by the International Organization of Standardization (http://www.cap.org/apps/cap.portal) to improve patient care, strengthen the deployment of quality standards, reduce errors and risk and control costs.

Clinical Laboratory Improvement Amendment (CLIA)