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  • Regulatory NewsRegulatory News

    EMA Releases Q&A on Exposure Limits and Hazardous Compounds

    The European Medicines Agency (EMA) on Monday released for public consultation a new question and answer document focused on the risk-based prevention of cross contamination in pharmaceutical manufacturing and setting health-based exposure limits for risk identification. The 14 questions and answers hone in on specifics such as “Do companies have to establish Health Based Exposure Limits (HBELs) for all products?” (yes), which products or active substances are highly ha...