PPTAs Standards program provides global leadership for the plasma protein industrys goal of continuous improvement with a focus on safety and quality from the donor to the patient. The Standards program is transparent, credible, innovative and responsive to stakeholder and industry needs.
People around the world depend on therapies derived from human plasma proteins to treat conditions such as hemophilia, immune disorders, and other diseases or injuries. Safety of plasma protein therapies is the top priority of the plasma fractionation industry. The Plasma Protein Therapeutics Association (PPTA), on behalf of its industry members, supports efforts by regulatory authorities to establish minimum requirements to ensure the safety of these products.
PPTA has adopted Voluntary Standards that go beyond regulatory requirements and help define the regulations as they apply to fractionation of plasma for plasma therapeutics. These Voluntary Standards relate to collecting, processing and testing of Source Plasma by member fractionators. In 2000, PPTA established the QSEAL certification program to provide independent certification of adherence by fractionators to the Voluntary Standards.