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EMA: Concept paper on the need for a guideline on process validation of medicinal products containing biotechnology-derived proteins as active substance

06.06.2011
This concept paper addresses the need to develop guidance on process validation of biotechnology derived active substances.
The source of the news: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/06/WC500107128.pdf