It has been around a year since the International Council for Harmonisation adopted revised guidance on ensuring the viral safety of biotechnology products derived from cell lines of human or animal origin.
ICH Q5A(R2): ‘More Regulatory Flexibilities Than Hurdles’
CRO executive Horst Ruppach discusses the critical factors that drug manufacturers must consider to ensure compliance with the revised ICH Q5A(R2) guideline on biologics viral safety. Thorough documentation and proactive engagement with regulatory bodies are key to navigating the complexities of viral safety evaluation in biotechnology products, he says.
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