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Guidance on a strategy for genotoxicity testing and mutagenic hazard assessment of impurities in chemical substances.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
An independent research report.
Get help to classify ceramic articles for import and export.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
The MHRA is consulting with UK stakeholders to gather feedback and comments on an international guideline on the assessment and control of extractables and leachables.
Guidance and recommendations from the Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (COM).
Get help to classify organic chemicals that contain certain permitted additives or can be dissolved in water, for import and export.
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