EMEA publishes new Draft of "Guideline on Plasma derived Medicinal Products"

In February 2009 the European Medicines Agency published the Draft of the "Guideline on Plasma derived Medicinal Products" as revision 4. It lays down the requirements for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products and pays specific attention to the viral safety of these products.

The improvements in protein purification and molecular separation technology have made available a wide variety of products, with medical applications and the large number of donations which are pooled and the well recognized risks of virus contaminations made it necessary to revise this guideline.

The guideline describes specific requirements for plasma-derived medicinal products. These include collection and testing of starting materials, manufacturing of the different plasma-derived medicinal products, quality control issues and a special focus on the validation studies and more specifically the viral validation studies. It also covers plasma derivatives used as:

  • Excipients
  • Ancillary substances in medical devices (Directive 2000/7/EC amending Directive 93/42/EEC)
  • Investigational products as such or as excipients

In accordance with article 3 (sections 1, 2 and 6) of Directive 2001/83/EC, the scope does not cover blood, blood components or medicinal products prepared on a small scale for individual patients in accordance with a medical prescription, although many parts contained in this document may be pertinent.

You will find more information about that draft here.

Axel Schroeder
On behalf of the European Compliance Academy (ECA)

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