FDA
Name Author Year Link
Nucleic Acid Testing to Reduce the Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived Products U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research July 2009 Read More
FDA In Brief: FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research February 2021 Read More
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products U.S. Department of Health and Human Services Food and Drug Administration August 2020 Read More
Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry Center for Biologics Evaluation and Research December 2017 Read More
Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus Center for Biologics Evaluation and Research October 2012 Read More
Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of of HIV-1 and HCV Center for Biologics Evaluation and Research October 2004 Read More
Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors Center for Biologics Evaluation and Research July 2001 Read More
EMA
Name Author Year Link
Guideline on plasma-derived medicinal products Committee for Medicinal Products for Human Use (CHMP) July 2011 Read More
Guide to the preparation, use and quality assurance of blood components - 20th Edition European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS ) March 2020 Read More
Standards and specifications for blood establishments Official Journal of the European Union July 2016 Read More
PPTA (QSEAL)
Name Author Year Link
NAT Testing Standard Quality, Standard, Excellence & Leadership (QSEAL) PPTA June 2021 Read More
Other
Name Author Year Link
Regulatory GUIDELINE ON THE REGISTRATION OF HUMAN PLASMA-DERIVED THERAPEUTIC PRODUCTS (Singapore) Health Science Authority April 2018 Read More
Global
Name Author Year Link
WHO Recommendations for the Production, Control and Regulation of Human Plasma for Fractionation – Annex 4 WHO October 2005 Read More

The standards and guidance documents stated above are applicable only to the specified country/region, unless stated otherwise as being global in scope.

This information is intended for physicians and healthcare professionals only.

Product registration and availability vary by country. For more information on product availability, please contact us here.