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GMP及其在血站质量管理中的应用 被引量:3

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作者 沈行峰
机构地区 上海市血液中心
出处 《中国输血杂志》 CAS CSCD 北大核心 2000年第2期137-138,共2页 Chinese Journal of Blood Transfusion
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参考文献8

  • 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

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