GMP News No. 383
5 February 2004
At the end of 2003, two regulatory documents relevant for the blood-processing industry and blood donation centres were published.
November, EMEA's CPMP published a "Discussion Paper on the
Investigation of Manufacturing Processes for Plasma-Derived Medicinal
Products with Regard to vCJD Risk." The topicality of this subject is
underlined by the fact that, due to the significantly high number of vCJD
cases, plasma from British donors is still not fractionated and plasma from
French donors is fractionated only after a strict risk evaluation. According
to the current state of knowledge, one can neither prove nor disprove the
theory that vCJD can be transmitted by blood, blood plasma, or plasma
components. However, experiments have shown that the infectivity of
plasma-derived medicinal products can be reduced by means of suitable
You will find the CPMP document at
In mid-December, FDA's CBER published a Guidance for Industry on blood, plasma, and plasma components. This document was created in co-operation with the American Association of Blood Banks (AABB), America's Blood Centers (ABC), and the American National Red Cross (ARC). It gives details on the labelling requirements as well as on the donation and use of blood and blood products intended for transfusion.
The unabridged document can be downloaded from the CBER website: