QSEAL CERTIFICATION PROGRAM DESCRIPTION V1_6.pdf

PPTA QSEAL Certification Program Overview Purpose The purpose of this document is to describe the policies and processes that control and standardize the way in which Plasma Protein Therapeutics Association (PPTA) certifies plasma fractionation facilities. The certification program is known as Quality Standards of Excellence, Assurance, and Leadership (QSEAL). Intended audience The intended audience for this document includes: ? Regulatory agencies interested in applicable policies ? Association leadership responsible for high-level policy approval ? Fractionators seeking certification ? Association staff with responsibilities for steps in the certification process ? Other parties (e.g., patient groups) interested in the certification process Contact For further information about the PPTA Fractionator Certification Program, contact PPTA at (202)-789-3100 or in writing at: QSEAL Certification PPTA 147 Old Solomons Island Road Suite 100 Annapolis, MD 21401-3822 USA In this document In this document you will find information on the PPTA Fractionator Certification Program from two perspectives: the fractionator (Section A) and the administrator (Section B). Topic See Section PPTA QSEAL Certification of Plasma Fractionators A How PPTA Administers the Certification Program B PPTA QSEAL Certification Program Description Page 1 of 22 Version 1.6 January 2010 Section A PPTA QSEAL Certification of Plasma Fractionators Overview Background People around the world depend on therapeutics derived from human plasma proteins to treat conditions such as hemophilia, immune disorders, and other diseases or injuries. Safety of plasma protein therapeutics 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 bodies to establish minimum requirements to ensure the safety of these p