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Risk analysis of Nitrosamines impurities

  • In September 2019, the CMDh published the information note "Information on Nitrosamines for Drug Authorisation Holders". The document of the EMA/511347/2019, asks the MAHs for a risk assessment of the presence of nitrosamines in all chemically synthesised human medicines.
  • The risk assessment for human chemical medicines should be completed by 31 March, 2021 and by 1 July 2021 for biological medicines.
  • At Azierta, we offer a global service that covers the risk analysis, analytical phase and includes regulatory support with variation management.

We have a multidisciplinary team, with great experience implementing the ICH Q9 quality management regulations and in the evaluation and control of mutagenic impurities according to ICH M7

1. Analysis and prioritization

  • Prioritization of products taking into account MDD, treatment duration, therapeutic indication, and product order based on the number of units sold.

2. Risk assessment

  • Risk assessment of drugs containing chemically synthesized APIs according to ICH guideline Q9.

3. Confirmation tests

  • If a risk of nitrosamines is detected, confirmatory testing is required using equipment of high sensitivity and specificity that has been validated.
  • These impurities can be quantified by mass detectors associated with liquid (LC/MS) or gas chromatographs (GC/MS).
  • TACs should report immediately if testing confirms the presence of nitrosamines.

4. Regulatory variations

  • Request for modification, introducing the necessary changes, such as modification of the manufacturing process or changes in the product specifications.


We have a specialized area in toxicological support composed of a multidisciplinary team of expert toxicologists accredited by AETOX, EUROTOX and ERT.

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience


Leading innovation

Client oriented

100% client oriented


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