The plasma industry created an industry wide quality program to enhance product safety and the industry image.
The QSEAL mission statement states:
“PPTA’s voluntary standards program provides global leadership for the plasma protein industry’s goal of continuous improvement with a focus on safety and quality from the donor to the patient. The Standards Program will be transparent, credible, innovative, and responsive to stakeholder and industry needs.”
Human plasma is processed and used in dozens of different lifesaving plasma protein therapies. People who use these therapies manufactured from human plasma rely on the generous donations made by committed individuals. To further improve the quality and safety of source plasma, PPTA developed the International Quality Plasma Program (IQPP).
IQPP provides independent, third-party evaluation and recognition of a center’s adherence to global industry standards for source plasma.
IQPP certified centers provide manufacturers with the highest quality source material. IQPP certification focuses on:
- Donor Management and Donor Health
- Center Management
Donor Management and Donor Health Standards
- Community-based Donor Standard:
This standard only allows donors who permanently reside within the defined Donor Recruitment Area of the plasma center to donate at that center. The standard helps to maintain a steady and reliable donor population and supply of quality plasma.
- Cross Donation Management Standard:
Plasma donors may misunderstand the reasons for limiting the number of times that they can donate per week. Infrequently, a donor may attempt to donate more often than is allowed. While these are rare occurrences, it is necessary to take measures to protect the health of the donor and minimize the risk of cross donation. This standard addresses the potential risk of cross donation.
- Donor Adverse Events Recording Standard:
All IQPP-certified centers have processes in place to monitor, manage and document donor adverse events (DAEs). This standard requires that plasma centers classify and record DAEs in accordance with defined parameters.
- Donor Education Standard:
It is important that donations are collected from a low-risk donor population. This standard requires new donors to engage in an educational program and follow-up assessment regarding HIV/AIDS and activities that place them at risk for HIV/AIDS. The educational program also encourages donors to lead a healthy lifestyle
- Donor Fluid Administration:
This standard contains requirements to enhance donor safety by assisting donors in sustaining hydration on the day of donation. Plasma centers must administer fluids as part of the donation process.
- National Donor Deferral Registry® Standard (NDDR®):
This standard helps ensure that donors deferred for reactive test results do not donate in other facilities. Any individual who tests reactive for HIV, HBV or HCV must be entered into a national database (the NDDR®) used by all IQPP-certified centers in the U.S. All individuals presenting themselves for the first time are checked against the NDDR®. Those who have previously been deferred for reactive test results at any participating facility can quickly be identified and rejected utilizing this computerized database.
- Qualified Donor Standard:
Potential 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 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.
Center Management Standards
- 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 of the three viruses, the center will implement corrective actions that will bring the center into compliance with the standard.
- Personnel Education and Training Standard:
This standard ensures that the facility has knowledgeable and experienced staff that is highly trained in their job responsibilities. Additionally, this standard requires an in-depth initial training program and an ongoing training program. This ensures that the center staff is always up-to-date on the most recent regulatory requirements and latest and most innovative procedures.
- Professional Plasma Collection Facility Standard:
It is imperative that all facilities maintain a high level of professionalism and quality regarding their cleanliness, safety and appearance. This standard ensures that IQPP-certified centers uphold that level of professionalism and quality.
- Quality Assurance:
IQPP certified plasma centers are based on compliance with current Good Manufacturing Practices (GMP). This Standard is an enhancement to those requirements, focusing on the aspects of Complaint Resolution and Lot Release Procedures. This Standard ensures that a plasma center has put into place systems that consistently guarantee a quality product.
Adapted from PPTA web site