Description
We, FDA, are issuing this guidance to provide you, manufacturers of plasma-derived products, with recommendations for performing nucleic acid testing (NAT) for human parvovirus B19 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 FDA implementation of parvovirus B19 NAT.
Scope & Applicability
Product Classes
7Starting material for blood products tested for B19 DNA
High-purity plasma derivative associated with B19 transmission
Specific plasma derivatives treated for viral inactivation
Plasma-derived product where B19 DNA is less frequently detected
Plasma-derived product where B19 DNA is less frequently detected
Plasma-derived products where B19 DNA is frequently detected
Guidance for manufacturers of plasma-derived products regarding NAT testing; Products subject to nucleic acid testing for parvovirus B19
Stakeholders
1Responsible for declaring acceptable market names on labels.
Identified Hazards
Hazards
1Risk of morbidity to pregnant women and immune compromised individuals
Related CFR Sections (1)
See Also (8)
- Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application: Guidance for Industry (Status: Final)
- Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy: Guidance for Industry (Status: Final)
- Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products: Guidance for Industry (Status: Final)
- Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements: Guidance for Industry (Status: Final)
- Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Guidance for Industry (Status: Final)
- Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc): Guidance for Industry (Status: Final)
- Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection: Guidance for Industry (Status: Final)
- Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry: Guidance for Industry (Status: Final)