Zdroje

"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." - Mission Statement, PPTA Voluntary Standards Program

PPTA welcomes the revision of the EU pharmaceutical legislation as an opportunity to improve access to therapies, including life-saving plasma-derived medicinal products (PDMPs) for EU patients. A revised framework has the potential to provide a robust set of provisions that will continue to ensure the safety and quality of human plasma used for manufacturing, while upholding the safety, quality, and efficacy of PDMPs.

Facts about Qualified Donor Standard.

The Full-Length PPTA Donor History Questionnaire (DHQ) and Abbreviated Questionnaire are designed to aid plasma sourcing organizations in evaluating a prospective donor’s history relative to current known safety risks, FDA regulations and recommendations, PPTA voluntary standards, and optionally, European requirements. The Full-Length PPTA DHQ is designed as a stand-alone questionnaire that may be used at each donation. It may also be used in conjunction with an abbreviated form for frequent donors.