Mérieux NutriSciences invites you to participate in our free webinar on nitrosamines analysis to deep understand our technical best practices and analytical strategies for assuring pharmaceutical product’s safety.
The European medicines regulatory network extends all steps deadlines due to the impact of the severe restrictions in place to combat the covid-19 pandemic. In any case, the European medicines regulatory network encourages MAH to submit the outcome of their evaluations if they identify a risk in their products. Authorities also suggest that in order to meet these deadlines, it is necessary to perform the step 2 confirmatory testing activities sufficiently in advance. How?
Thanks to the long-standing experience in the chemical industries, our experts have been developing various strategies and approaches for the determination of nitrosamine residues in different matrices through sophisticated mass spectrometry technologies. During the webinar, we will present different case studies with a special hot topic on the presence of the N-Nitrosodimethylamine (NDMA) impurity in metformin approved for sale on the US market.
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The FDA and EMA request pharma industries to evaluate the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesized active ingredients. MAHs (Marketing Authorization Holders) of all human medicinal products containing chemically synthesized Active Pharmaceutical Ingredients (APIs) should work with the manufacturers of their APIs and finished products in order to evaluate the risk of nitrosamines being present in their products, and take appropriate risk-mitigating measures. All authorized human medicinal products containing chemically synthesized APIs must be reviewed, including generics and over-the-counter (OTC) products. In view of the large number of authorized products, MAHs should use a risk-based approach and prioritize their evaluations and confirmatory testing.
MAHs should inform the competent authorities as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected. The immediate risk to patients should be assessed and appropriate action taken to avoid or minimize the exposure of patients to nitrosamines. At all steps, timelines should be shortened and MAHs should immediately inform authorities if findings indicate an immediate risk to public health:
Step 1: Risk evaluation
- 31 March 2021 for chemical medicines
- 1 July 2021 for biological medicines
Step 2: Confirmatory testing
Perform further confirmatory testing on the products identified to be at risk of N-nitrosamine formation or (cross-)contamination and report confirmed presence of nitrosamines as soon as possible.
Step 3: Update marketing authorizations
- 26 September 2022 for chemical medicines
- 1 July 2023 for biological medicines