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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.
Get help to classify ceramic articles for import and export.
An independent research report.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Get help to classify organic chemicals that contain certain permitted additives or can be dissolved in water, for import and export.
A summary of the main methods you should use to monitor for particulate matter in ambient air.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
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