11,Code of Federal Regulations.21CFR 200 to 299.Washington:Government printing office,1992
22,Code of Federal Regulations.21CFR 600 to 799.Washington:Government printing office,1992
33,The rules governing medicinal products in the European Community.Vol.IV.Good Manufacturing Practice for Medical Products.Luxembourg:Office for Official Publications of the EC,1992
44,Solomon TM.The evolution of the current blood banking regulatory climate.Transfution,1994;34∶272
55,Rossi EC,Simon TL,Moss GS,et al.Principles of transfusion medicine.Baltimore:Williams & Wilkins,1996;2ed∶885
66,Guideline for quality assurance in blood eslablishments.center for biologics evaluations and research,FDA,June 17,1993
78,Miller WV.Blood banks should use good manufacture practice and the pharmaceutical manufacturing approach:Pro.Transfuusion,1993;33∶435
89,Menitove JE.The recent emphasis on good manufacture practices and the pharmarceutical manufacture approach damages blood banking and transfusion medicine as medical care activities:con.Transfusion,1993;33∶439