People around the world depend on therapies derived from human plasma proteins to treat bleeding disorders, primary immune deficiencies, Alpha-1 antitrypsin disease and certain neurological conditions. Plasma protein therapies are also used in emergency and surgical medicine.
Safety of plasma protein therapies is the top priority of the plasma fractionation industry. 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 collection, processing and testing of source plasma by fractionators. In 2000, PPTA established the QSEAL Program to provide independent certification of adherence by fractionators to the voluntary standards.
QSEAL Voluntary Standards
- Controls on Incoming Plasma
Delineates the QSEAL responsibilities of the manufacturer with respect to the quality and safety of incoming plasma used for manufacturing plasma protein therapies. It places controls on a manufacturer’s incoming plasma, regardless of its source.
- Inventory Hold
Collected plasma is held in inventory for at least 60 days after donation to allow for retrieval and destruction of plasma based on post-donation disqualifiers such as high-risk behavior, testing reactive for HIV, HBV or HCV or international travel.
- Nucleic Acid Amplification Technology (NAT) Testing
Requires Nucleic Acid Amplification Technology (NAT) Testing for HIV, HBV and HCV at the donation (minipool) level and again at the first homogeneous plasma pool level. Also requires in-process testing for HAV and Parvovirus B19.
- Intermediates Purchased from an External Supplier
Mandates a contract chain between the supplier and purchaser of intermediates, for traceability from each donation to the final product.
- Recovered Plasma Specification
Specifies acceptance criteria for manufacturing facilities that use Recovered Plasma including infrequent source plasma collected by blood establishments. The goal is to assure the residual risk of the manufacturing pool is comparable to that for Source Plasma.
- Qualified Donor
Potential source plasma donors must pass two separate medical screenings and testing for HIV, HBV and HCV on two different occasions. Only after satisfactory screenings and negative test results does that person become a Qualified Donor. If a donor does not return within six months, that person loses his/her Qualified Donor status and must qualify again. This standard means that source plasma from a one-time-only donor (even when all test results are negative) cannot be used for further manufacture. The standard results in committed donors and eliminates the risk that so-called "test-seekers" are accepted.
- Viral Marker
It is important that donations are collected from a low-risk donor population. This standard focuses on that element. Each source plasma collection center is obliged to report its viral marker rates for HIV, HBV and HCV in the donor population. The center's rates are compared to the industry average. Alert limits are set to take into account the number of annual donations. If a center exceeds the limit for any of these viruses or the aggregate of the three viruses, the center will implement corrective actions that will bring the center into compliance with the standard.
Additional QSEAL Documents
- Application Form for Initial Certification
- Application Form for Recertification
- Audit Report Form and Checklist
- Certification Program and Description