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美国原料血浆采集的质量管理 被引量:3

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出处 《中国输血杂志》 CAS CSCD 北大核心 2009年第4期336-339,共4页 Chinese Journal of Blood Transfusion
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参考文献20

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同被引文献42

  • 1章金刚.生物技术产品的病毒安全性[J].中国医药生物技术,2007,2(2):81-84. 被引量:7
  • 2FDA. Guideline for quality assurance in blood establishment ( 1995 ) [ S/OL ]. 1995-07-11 [ 2009-10-13 ] http ://www. fda. gov/downloads/BiologicsBloodVaceines/GuidanceCompliance- RegulatoryInformation/Guiadnces/Blood/UCM 164981. pdf.
  • 3Code of Frederation of Regulation. Current good manufacturing practice for blood and blood components. Washington : US Goveminent Printing Office, 1998-04 BioLife Plasma Services. About Biolife-Press kit [ OL]. http:// www. biolifeplasma. com/html/about _ biolife/BioLife _ PressKit.
  • 4WHO. Twenty-eighth world health assembly. WHA28.72 Utilization and supply of human blood and blood products. Geneva : WHO, 1975-03-13-30 [ 2009-10-13 ] http: //www. who int/ bloodsafetg/en/WHA28.72.pdf.
  • 5WHO. Twenty-eighth world health assembly. WHA28.72 Utilization and supply of human blood and blood products. Geneva : WHO, 1975-03-13-30 [ 2009-10-13 ] http: //www. who int/ bloodsafetg/en/WHA28.72, pdf.
  • 6WHO. Requirements for the collection, processing and quality control of blood components and plasma derivatives (revised 1992)//WHO,technical report series No 840[ S/OL]. Geneva: WHO, 1994 [ 2009-10-14 ] http ://www. who. int/bloodproducts/ publications/WHO.TRS_840-A2. pdf.
  • 7WHO. WHO expert committee on biological standardization. 52 nd Report [ S/OL]. [ 2009-10-13 ] http://whqlibdoc.who. int/ trs/WHO. TRS_924. pdf.
  • 8PIC/S Secretariat. PIC/S GMP guide for blood establishments [ S/OL]. 2004-01 [ 2009-09-13 ], http://www. who. int/bloodproducts/publications/en/_20005-2 _ PTCS _ GMP _ Guide - for_ Blood_Establishments. pdf.
  • 9Council of Europe, Guide to the preparation, use and quality assurance of blood components( 1995 ). Brussels :Council of Europe Publishing, 1995 : 113-139.
  • 10Therapeutic Goods Administration. The Australian code of good manufacturing practice (GMP) for blood and blood products[ S/ OL]. 2000-08-24[ 2009-10-13 ] http ://www. tga. gov. au/manuf/ gmpbltic.pdf.

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