Application of quality assurance practices in processing cells and tissues for transplantation.
Attention to issues of quality assurance from the early stages of development of experimental cell therapies provides a margin of safety for recipients. Adherence to minimum standards of practice at acquisition, processing, storage, and implantation ensures not only this baseline safety factor for patients, but also provides a baseline for comparative evaluations between different studies or different banks. This paper describes the basic components of a quality assurance program tailored to laboratories and facilities that collect, process, or distribute human cells and tissues for transplantation. These components include policy and procedure manuals, donor screening practices, processing procedures evaluation and control, training and education programs, auditing and investigation roles, responsibility for release of grafts, and recordkeeping and traceability requirements. References and resources for detailed information related to good manufacturing practices and good clinical and laboratory practices are provided. Standards, regulations, and current legislation specifically related to human cells and tissues intended for transplantation are also discussed.
Newman-Gage
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Department of the Puget Sound Blood Center, Seattle, WA 98104, USA.
D015925:Cryopreservation; D017408:Guidelines as Topic; D006801:Humans; D016134:Organizational Policy; D011996:Records; D012106:Research / Q000592:standards; D012926:Social Control, Formal; D014015:Tissue Banks / Q000592:standards*; D014019:Tissue Donors; D014021:Tissue Preservation; D016378:Tissue Transplantation; D014481:United States; D014486:United States Food and Drug Administration