The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

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: ,

Document Type:
Guidance for Industry
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.

Go back

GMP Conferences by Topics