1. FDA Memorandum, Docket No. 91N-0450, Guideline for Quality Assurance in Blood Establishments. July 11, 1995
2. FDA Memorandum, Guideline on General Principals of Process Validation. May, 1987
3. Standards for Blood Banks and Transfusion Services. Bethesda, MD: American Association of Blood Banks, 18th ed. 1997:67
4. FDA Memorandum, document #4027, Recommendations and licensure requirements for leukocyte-reduced blood products. May 29, 1996
5. Practical guidelines for process validation and process control of white cell-reduced blood components: report of the Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion (ISBT);Dumont;Transfusion,1996