I’ m a new here, everybody, Hello!
Can I ack, do you have SOP for Nitrosamine Impurities?
And second : Do you have template for Risk Assessment Report for This topic ?
Great site, by The way!!!
Wish you all Health and Success in 2021 year!
Please refer EMA European guidelines, "Information on nitrosamines for marketing authorisation holders Request to evaluate the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesised active pharmaceutical ingredients- 19 September 2019.
Also please refer USFDA guidance on “Control of Nitrosamine Impurities in Human Drugs” Sept 2020.
In June 2018, authorities in the EU became aware of the presence of a nitrosamine, Nnitrosodimethylamine (NDMA), in valsartan from one manufacturer of active pharmaceutical
ingredients (APIs). Subsequently another nitrosamine, N-nitrosodiethylamine (NDEA), was detected
and other sartans from more API manufacturers were later implicated. NDMA and NDEA are classified
as probable human carcinogens and their presence in sartans was, at the time, unexpected.
An Article 31 review of sartans at risk of containing nitrosamine impurities (i.e. sartans with a tetrazole
ring) concluded that manufacturers must review and make necessary changes to their manufacturing
processes to minimise nitrosamine impurities as much as possible. In addition, strict limits were set for
nitrosamines in these products.
The findings of the review indicate that there is a potential for nitrosamines to be present in APIs for
other medicines (i.e. non-sartans APIs), depending on the API and the finished product manufacturing
Nitrosamines are not expected to be formed during the manufacture of the vast majority of APIs
outside the class of sartans with a tetrazole ring. However, it is now known that these impurities can
form during production under certain conditions and when certain solvents, reagents and other raw
materials are used. In addition, impurities can be carried over during the manufacturing process when
using already-contaminated equipment or reagents. Furthermore, in cases where nitrosamines can
form or are carried over during production, the impurities should normally be controlled and removed
during the manufacturing process. Therefore, despite the low risk of nitrosamines being present,
Marketing Authorisation Holders (MAHs) are asked to take precautionary measures to mitigate the risk
of nitrosamine formation or presence during the manufacture of all medicinal products containing
chemically synthesised APIs.
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