QA for Clinical Trials Compliance
QA helps to ensure the manufacturing and testing of products used for Phase I/II clinical trials comply with the Food and Drug Administration’s (FDA) current Good Manufacturing Practices (cGMP), current Good Tissue Practices (cGTP), and other applicable regulations. QA oversight of the quality systems, and review, approval, and release of final products ensures regulatory compliance and safety of final products intended for human clinical use.
QA is responsible for approving or rejecting raw materials and finished products used or manufactured by Fred Hutch manufacturing facilities, approving documentation and procedures that may impact identity, purity, strength, quality, safety, potency, or efficacy of products manufactured by FHCRC therapeutics manufacturing facilities, approving production batch records, performing internal and external quality audits, and approving failures investigations.
To obtain additional information, contact QA personnel at (206) 667-5060.