Manufacturing of Plasma-Derived Medicinal Products: Qualification Process of Plasma Suppliers.

Abstract

Manufacturers of human plasma-derived products ensure, through their qualification departments, the quality and safety of human plasma-the biological starting material of the industrial fractionation process. The qualification department has established written procedures to approve the plasma supplier (i.e., initial qualification) according to current regulations and to the manufacturer's plasma specifications. Once the plasma supplier is approved, a periodical assessment is necessary (i.e., continuous qualification) to guarantee the level of compliance. In addition, a signed quality agreement between the plasma supplier and the manufacturer defines the duties and the responsibilities of both parties. The qualification department implements the following requirements to ensure the quality of plasma from suppliers: (i) a regular audit program to confirm the satisfactory initiation of the quality arrangements and (ii) monitoring of the quality and safety of plasma including critical quality parameters. For several years, the Grifols Qualification Department has worked with several plasma suppliers of the European Union (EU) and has performed a detailed, continuous assessment of the audits, deviations, operational incidences, epidemiological data, and quality controls. In this article, we will report data from this Grifols assessment from 2010 through 2013 on plasma suppliers from four EU countries. In the future, additional data will be collected and studied to confirm and verify the conclusions and trends observed in this study.