PPTA and Member Companies Demonstrate Sustained Commitment to Patient Safety (June 26, 2013)
, a voluntary standards program designed to enhance the safety and quality of therapies derived from human plasma and to ensure the uniform application of industry standards throughout the world.
Companies who obtain QSEAL certification are subject to regular inspections by an independent auditor to assess their compliance with program requirements. Participating companies are evaluated against standards for controls on incoming plasma, manufacturing practices and adoption of viral marker testing.
The revisions to the QSEAL standards, the first in a decade, promote state-of-the-art manufacturing processes. The revised standards place manufacturer controls on incoming plasma regardless of its origin, including plasma from whole blood donations, otherwise known as Recovered Plasma.
“PPTA applauds the fractionators who have gone the extra mile to have their facilities certified for compliance with the QSEAL standards. QSEAL certification demonstrates a company’s commitment to excellence and distinguishes it from its peers in the industry,” said Jan M. Bult, PPTA President and CEO.
Lifesaving plasma protein therapies include plasma-derived and recombinant blood clotting factors. These unique, biologic products for which no substitute therapies exist, are used to treat bleeding disorders, primary immunodeficiency diseases, Alpha-1 antitrypsin deficiency and certain rare neurological disorders, and are also used in emergency and surgical medicine.
PPTA member companies that have achieved QSEAL certification and operate manufacturing facilities in the U.S. and Europe are: Baxter Bioscience, Biotest, CSL Behring, Grifols and Kedrion.
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