Safety and Quality

Safety and quality of plasma protein therapies is the top priority of the plasma protein therapeutics industry. Both collectors and manufacturers adhere to strict regulatory policies and have instituted Good Manufacturing Practices in every step of plasma collection and manufacturing processes.

Furthermore, PPTA member companies have adopted voluntary standards and other criteria that apply to the collection and fractionation of plasma for plasma protein therapies. These robust programs showcase the industry's commitment to continuous improvement and help to ensure the availability of effective and high-quality plasma protein therapies. Combined, they put quality and safety in the forefront for patients worldwide.

To further improve the quality and safety of source plasma, PPTA developed the International Quality Plasma Program (IQPP) which provides independent, third-party evaluation and recognition of a center's adherence to global industry standards for source plasma.

Established in 2000, the Quality Standards of Excellence, Assurance and Leadership (QSEAL) provides voluntary standards related to the collection, processing, and testing of source plasma by fractionators.