FAQ - human plasma for fractionation

How is a traceability procedure (look back) to be carried out in accordance with the current state of the art in science and technology?

Directives 2002/98/EC and 2005/61/EC adopted by the European Parliament and the Council as well as GMP Annex 14 demand the complete traceability of blood and plasma donations in the member states. The Guideline on plasma-derived medicinal products EMA/CHMP/BWP/706271/2010 issued by CHMP specifies the cases in which traceability proceedings must be initiated.

Minimum measures applicable to the plasma processing industry concerning traceability procedures (look back) can be found in the guideline "Implementation of traceability of human plasma for fractionation" below.


Further inquiry note