From people -
for people
Carefully Selected
Donor Centers
Selection of Healthy
Plasma Donors
High Quality
Plasma
Incoming Plasma
Control
Small Plasma
Batches
Virus Inactivation
Good Manufacturing
Practice
Quality Assurance
& Quality Control
Laboratory Batch
Release
Controlled storage
and Shipment
Clinical Evaluation
Pharmacovigilance
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Selection of Healthy Plasma Donors
The qualification procedure for donors involves the following selection criteria (in compliance with EU and FDA guidelines):
- Acceptable medical history
- Acceptable medical examination and laboratory tests
- Successful personal interview
- Low risk behaviour with regard to virus transmission
- Absence of sexually transmitted diseases
- Not listed in the National Donor Deferral Registry (U.S. plasma centres)
- Normal serum protein level
- Normal hemoglobin level
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