GMP topical

08.07.2021

EMA: Revised Q&A on assessment of nitrosamine impurities

On 2 July 2021 the European Medicines Agency has released a revised version of the 17-pages Q&A to aid marketing authorisation holders to assess their risk for nitrosamine impurities. The revision affects questions 3 and 10:

For the ‘call for review’ for chemically synthesised and biological medicinal products, when and how should MAHs report steps 1 and 2 to competent authorities? (Q&A 3)
Which limits apply for nitrosamines in medicinal products? (Q&A 10).

Question 3 refers to the submission templates for Step 2 "Confirmatory testing".

The template "Step 2 - Nitrosamines detected above acceptable intake or new nitrosamine detected response template" should only be used in addition to the "Step 2 -Nitrosamines detected response template" if

the specified acceptable intake limit for the nitrosamine is exceeded
the corresponding lifetime excess cancer risk of 1:100000 is exceeded
it is a newly identified nitrosamine not covered in CHMP Article 5 (3), irrespective of the amount detected

Important deadlines for MAHs to submit their confirmatory tests under step 2:

for products containing chemically synthesised active substances: by 26 September 2022
for products containing biological active substances: by 1 July 2023

Question 10 newly lists N-nitrosomorpholine, NMOR with a limit of 127 ng/g .

GMP topical

EMA: Revised Q&A on assessment of nitrosamine impurities

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