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Quality Standards of Excellence, Assurance and Leadership (QSEAL)

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.

 QSEAL Program Description

QSEAL Voluntary Standards:

• Intermediates:  A contract chain must exist between the supplier and the purchaser of the intermediate that specifies quality requirements, which are verified through initial and subsequent regular quality assessments, e.g. audits. 
• Inventory Hold:  This standard states that collected plasma will be held in inventory for at least 60 days from the time of collection. This allows for the retrieval of units as a result of post-donation information (information that was not known at the time of donation) that would have disqualified the donor. This information could include anything from admitting high-risk behavior, becoming reactive for HIV, HBV or HCV, or providing incorrect information about international travel.
  
• Nucleic Acid Amplification Technology (NAT) Screening:  The use of Nucleic Acid Amplification Technology (NAT) screening allows the detection of units reactive for HIV, HBV and HCV much earlier in an infection than conventional serological testing technologies and, therefore, limits the window period. Companies are free to determine where they apply the NAT screening, either on units, mini-pools or fractionation pool.
  
  • NAT Technical Considerations
• Parvovirus B19:  Incoming plasma is tested for Parvovirus B19 and manufacturing pools prepared from NAT-screened incoming plasma will not exceed 105 IU Parvovirus B19 DNA/ml before entering the viral inactivation and removal steps in the production process.
• Qualified Donor:  Potential donors must pass two separate medical screenings and testing for HIV, HBV and HCV on two different occasions. Only after those 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 plasma from a one-time-only donor (even when all test results are negative) cannot be used for further manufacture of life-saving therapies. The standard results in committed donors and eliminates the risk that so-called "test-seekers" are accepted.
• Viral Marker Standard:  It is important that donations are collected from a low-risk donor population. This standard focuses on that element. Each 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, the center will implement corrective actions that will bring the center into compliance with the standard.

QSEAL Applications

• Application Form for Initial Certification

• Audit Preparation
• Audit / Inspection Checklist
  

The following companies are currently QSEAL-Certified:

	Re-certified in 2012 [Certified in 2001]
	Re-certified in 2010 [Certified in 2001]
	Re-certified in 2012 [Certified in 2001]
	Re-certified in 2012 [Certified in 2001]
	Re-certified in 2012 [Certified in 2010]