Nitrosamine impurities, including N-Nitrosodimethylamine (NDMA),
and N-Nitrosodiethylamine (NDEA), are probable human carcinogens, and
N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) is a potential human carcinogen.
In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in a number of blood pressure medicines known as ‘sartans’. This led to some product recalls and to a regulatory review, which set strict new manufacturing requirements for these medicines. Subsequently, a nitrosamine impurity has been detected in batches of ranitidine, a medicine used to treat heartburn and stomach ulcers, and metformin-containing medicines.
Marketing authorisation holders should review their manufacturing processes to identify and, if necessary, mitigate the risk of presence of nitrosamine impurities in three steps: risk evaluation, confirmatory changes, changes to the manufacturing process.
The European medicines regulatory network encourages marketing authorisation holders to submit the outcome of risk evaluation before
1 October 2020 if they complete the risk evaluation or identify a risk in their products.
Contact us for further information, if you seek support in risk evaluation as well as issues of quality risk management processes within GMP compliance: firstname.lastname@example.org