1[4]Zhang JG.Viral safety for animal-derived products//British Council.China-UK Workshop on food safety,Zhengzhou,2006.Beijing:British Council Beijing Branch,2006:27-28.
2[7]WHO.Requirements for the use of animal cells as in vitro substrates for the production of biologicals.WHO Technical Report Series,No.927,2005[EB/OL].[2007-03-23].http://www.who.int/biologicals/areas/blood_products/ANNEX%204%20Animal%20cellsP135-137.pdf.
3[8]Committee for Proprietary Medicinal Products NOTE for guidance on virus validation studies:the design,contribution and interpretation of studies validating the inactivation and removal of viruses[EB/OL].(1996-02-14)[2007-03-23].http://www.emea.eu.int/pdfs/human/bwp/026895en.pdf.
4[9]Committee for Proprietary Medicinal Products.NOTE for guidance on plasma-derived medical products[EB/OL].(2001-01-25)[2007-03-24].http://www.emea.eu.int/pdfs/human/bwp/026995en.pdf.
5[10]ICH.Note for guidance on quality of biotechnological products:viral safety evaluation of biotechnology products derived from cell lines of human or animal origin[EB/OL].(2001-01-25)[2007-03-24].http://www.tga.gov.au/docs/pdf/euguide/ich/29595en.pdf.
6[11]U.S.Department of Health and Human Services,Food and Drug Administration,Center for Biologics Evaluation and Research.Characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases[EB/OL].(2006-09-28)[2007-03-19].http://www.fda.gov/cber/gdlns/vaccsub strates.pdf.
7[12]Center for Biologics Evaluation and Research,Food and Drug Administration.Points to consider in the characterization of cell lines used to produce biologicals[EB/OL].(1993-06-12)[2007-03-20].http://www.fda.gov/cber/gdlns/ptccell.pdf.
8[13]U.S.Department of Health and Human Services,Food and Drug Administration,Center for Biologics Evaluation and Research,Food and Drug Administration.Points to consider in the manufacture and testing of monoclonal antibody products for human use[EB/0L].(1997-02-27)[2007-03-19].http://www.fda.gov/cber/gdlns/ptc_mab.txt.
9[14]State Food and Drug Administration.Guideline for viral removal/inactivation techniques and validation of blood products[EB/OL].(2002-05-09)[2007-03-22].http://www.sda.gov.cn/cmsweb/webportal/W4244/A6319285.html.(in Chinese)国家食品药品监督管理局.血液制品去除/灭活病毒技术方法及验证指导原则[EB/OL].(2002-05-09)[2007-03-22].http://www.sda.gov.cn/cmsweb/webportal/W4244/A6319285.html
10[16]U.S.Department of Health and Human Services.PHS Guideline on infectious disease issues in xenotransplantation[EB/OL].(2001-01-19)[2007-03-20].http://www.fda.gov/cber/gdlns/xenophs0101.pdf.
