Wednesday, 20 November 2013

Virus testing of raw materials


The European Medicines Agency have issued some reports examining the necessity of screening certain in-coming raw materials for viruses.

These are:

Use of bovine serum in the manufacture of human biological medicinal products. Reference: CPMP/BWP/1793/02. Issued in June 2013.

With this document, the guidance notes: “Different risks are associated with the use of such raw materials. Indeed, the nature and quality of the bovine serum used in the manufacturing process can profoundly influence the quality of the finished product. In particular, the potential presence of extraneous agents in bovine serum represents a risk to the safety of the biological medicinal product.”

Use of porcine trypsin used in the manufacture of human biological medicinal products. Reference: EMA/CHMP/BWP/814397/2011. Issued in March 2013.

Posted by Tim Sandle

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