FEIBA Patient Information Booklet - Haemophilia Care

Protecting patients: the Baxter
plasma safety programme
In the production of plasma-derived treatments such as FEIBA, patient safety
is of paramount importance.
By adhering to the most stringent plasma safety regulations, Baxter is
exceeding standard industry practices, dedicating efforts to advancing plasma
safety. In fact, Baxter is a world leader in all aspects of plasma-derived
therapeutic safety from initial donor selection to final product formulation.
We source plasma from our own plasmapheresis centres or from centres
that meet Baxter standards. Our plasma screening standards meet or exceed
all industry and regulatory requirements.
As a result, you can be confident that everything possible has been done
to ensure the safety of FEIBA.
Protecting patients: the Baxter
plasma safety programme
Our safety measures include
• One of the first companies to receive QSEAL (Quality, Standards of
Excellence, Assurance, and Leadership) certification which recognises
the company’s commitment to outstanding quality and safety in
plasma sourcing and manufacturing
Strict selection of plasma donors according to the
Qualified Donor Standard
• All donor applicants have to go through two sets of screening interviews
(covering case history, high-risk behaviour inquiry, physical examination)
and laboratory tests before being a qualified donor
• All donations made by donors that do not come back for a second
donation are automatically discarded
60-day inventory hold period of all plasma donations
to ensure safety of donation
• The inventory hold period allows each donation to be virus-tested
(and discarded if positive) before it goes into the manufacturing process
• It also gives sufficient time to receive post-donation information about
donor and to discard any single donations
18
19