EMA: Updated Q&A on Nitrosamines in Human Medicinal Products
EMA has updated ist questions and answers for marketing authorisation holders/applicants on nitrosamine impurities in human medicinal products.
Q&A 10 has been updated to clarify the applicable AI limit to different administration routes and accepted in vivo study type.
Q&A 22 has been amended to highlight the expectations for the submission of variations to shelf-life and storage conditions as needed to comply with interim limit during CAPA implementation.
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