- 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 all products should be completed by October, 1st 2020.
- 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.