Friday, 8 February 2013

Risk identification: different medicinal products in shared facilities

Risk identification in the manufacture of different medicinal products in shared facilities

The European Medicines Agency has published a draft document titled: “EMA: Guideline - setting health based limits for risk identification in the manufacture of different medicinal products in shared facilities”.  According to the guide: “When different medicinal products are produced in shared facilities, the potential for cross contamination becomes an issue for concern.”  The guide attempts to set out regulatory advice in relation to this. CHMP / CVMP has published this document for comment by 30 June 2013.

To view the draft, see EMA

Posted by Tim Sandle

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