淺析美國原料血漿采集的質(zhì)量管理doc(完整版)
【正文】 SOP中詳細描述其采漿方法。采漿機構(gòu)在對CBER的年度報告中應注明標簽的任何變動和修改[4，5]。2008. [6]FDA：Guideline for quality assurance in a blood establishment，July 11，1995. , 20090410[7]FDA：Guidance for industry —Notifying FDA of fatalities related to blood collection or transfusion，9，2003. , 2009328[8]FDA：Revised Remendations for Red Blood Cell Immunization Programs for Source Plasma Donors，March 3，1995. , 200941[9]FDA: Informed consent remendations for source plasma donors participating in plasmapheresis and immunization programs，June，2007. , 2009320[10]FDA: Guide of Inspections of Source Plasma Establishments, June, 1997 (APRIL 2001 Editorial Revisions). , 2009418[11]FDA: Draft Reviewers’ Guide disease associated antibody collection program. :/, 200944[12]FDA：Guideline for collection from high risk donors (4/17/91) Date: April 17, 1991. , 2009422[13]FDA：Guideline for collection of blood or blood products from donors with positive tests for infectious disease markers (High Risk Donors)，October 26, 1989. , 2009421[14]FDA: Remendations for the management of donors and units that are Initially reactive for Hepatitis B surface antigen (HBsAg), December 2, 1987. , 2009420[15]FDA: Revised remendations for testing whole blood (8/5/93), 2009423[16]FDA：Donor screening assays for infectious agents and HIV diagnostic assays. Updated: February 26, 2009. , 2009420[17]FDA：Guide to inspections of infectious disease marker testing facilities, June 1996. , 2009421[18]FDA：Guidance for Industry: Revised remendations regarding invalidation of test results of licensed and 510(k) cleared bloodborne pathogen assays used to test donors,” dated July 11, 2001. , 2009424[19]FDA：Donor deferral due to red blood cell loss during collection of source plasma by automated plasmapheresis，December 4, 1995. , 2009421[20]FDA: Volume limits Automated collection of source plasma (11/4/92). , 2009425。同時，F(xiàn)DA和
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