New Guidelines and Regulations for the Blood-Processing Industry 

GMP News No. 383

GMP News
5 February 2004
 

 New Guidelines and Regulations 
 for the Blood-Processing Industry 

 
At the end of 2003, two regulatory documents relevant for the blood-processing industry and blood donation centres were published.

In 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 production steps.
The discussion paper presented by CPMP is meant to be used as a basis for the development of a checklist for evaluating the vCJD risk of a manufacturing process.

You will find the CPMP document at
www.emea.eu.int/pdfs/human/bwp/513603en.pdf.

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:
www.fda.gov/cber/gdlns/circbld.pdf.

Author:
Dr Ulrich Herber
CONCEPT HEIDELBERG
   

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