Kedrion has been awarded Quality Standards of Excellence, Assurance, and Leadership (QSEAL) certification from the Plasma Protein Therapeutics Association (PPTA).
The international QSEAL Program relies on independent, third-party evaluation and recognizes strict adherence to a set of voluntary standards, which underscore the industry’s quality and safety commitment to patients who rely on essential plasma protein therapies.
In order for a manufacturer of plasma protein therapies to become QSEAL certified, each one of its manufacturing facilities must pass inspection by an independent auditor for adherence to the QSEAL standards. To maintain QSEAL certification, audits are required every two years. The primary focus of the QSEAL audit is to assess adherence to multiple standards including the strict selection of qualified plasma donors; the implementation of a 60-day inventory hold that allows time to assure that only the highest quality of plasma is used to produce therapies; the use of advance nucleic acid amplification testing technology (NAT); a test for Parvovirus B19, a common infection that is often asymptomatic; and an intermediates standard that further assures the consistency, quality and traceability of intermediate products being incorporated into final therapies by manufacturers.
