FDA Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products 7/30/2008
Title:
FDA Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products 7/30/2008
Origin/Publisher:
www.fda.gov , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm078510.pdf
Document Type:
Guidance for Industry
Content:
This guidance should provide you, manufacturers of plasma-derived products, with recommendations for performing parvovirus B19 nucleic acid testing (NAT) as an in-process test for Source Plasma and recovered plasma used in the further manufacturing of plasma-derived products. Such testing will identify and help to prevent the use of plasma units containing high levels of parvovirus B19. This guidance also recommends how to report to the FDA implementation of parvovirus B19 NAT.