international quality plasma program iqpp

In 2000, the PPTA began QSEAL certification of those plasma fractionators that adhere to these PPTA Voluntary Standards. These standards go beyond what is required by law thus adherence to them is voluntary. In 1999, the PPTA added a fifth standard, to implement NAT for parvovirus B19 as soon as feasible. These standards include 1) nucleic acid testing (NAT) of source plasma for HIV, HBV, and HCV 2) use of only qualified donors (donors that pass physical and laboratory testing twice) 3) 60-day hold on all plasma to allow for retrieval of any suspect unit and 4) viral marker standards that all source plasma must meet. PPTA originally adopted four voluntary standards related to the collecting, processing, and testing of source plasma for use by PPTA members to manufacture clotting factors. In 1997, the PPTA implemented what is now known as the Quality, Safety, Excellence, Assurance and Leadership (QSEAL) certification program for manufacturers. These standards and objectives includeģ) recruiting of donors from the local community and avoidance of persons with known high risk activities,Ĥ) participation in the PPTA National Donor Deferral Registry (NDDR), IQPP certification incorporates a number of standards and objectives relating to the quality of a facility's donors and its plasma collection operations. In 1991, the PPTA initiated what is now known as the International Quality Plasma Program (IQPP) certification program for donor collection facilities. Information about the aggregated distribution of plasma protein therapies in Europe is provided through PPTA’s European Distribution Data Program, available here.The Plasma Protein Therapeutics Association (PPTA) is a worldwide association of manufacturers of products from human plasma such as clotting factor concentrates.is provided through PPTA’s North America Distribution Data Program, available here. Information about the aggregated distribution of plasma protein therapies in the U.S.View annual donation totals for Europe and the U.S. Each year, millions of plasma donations are made across Europe and the United States at IQPP certified centers.Plasma Collection & Availability of Plasma Products in Europe and the U.S. National Donor Deferral Registry (NDDR ®).Quality Standards of Excellence, Assurance and Leadership (QSEAL).International Quality Plasma Program (IQPP).

PPTA also administers standards and programs that help ensure the quality and safety of plasma collection and manufacturing and protect both donors and patients. Collaborate with patient advocacy organizations.Engage in constructive dialogue with regulatory agencies.Advocate for access to and affordability of therapies for patients.

International quality plasma program iqpp