The presence of the nitrosamine, N-nitrosodimethylamine (NDMA), in certain sartan API’s has resulted in several regulatory warnings and recall of contaminated products.
In September 2019, the EMA and other regulatory authorities instructed all pharmaceutical manufacturers to conduct a risk assessment and proactively test their products to protect patients and ensure that effective measures are taken to prevent the presence of nitrosamine impurities in human medicines by the end of March 2020.
Marketing authorization holders will then have until September 26, 2022, to perform further confirmatory testing on the products identified to be at risk of N-nitrosamine formation or cross-contamination and take mitigation measures where risks are identified, starting with the highest risk products.
This webinar will explore how you can meet the international nitrosamine detection regulatory requirements.
- Nitrosamine impurities in drugs – regulatory requirements
- Risk assessment and testing
The webinar is aimed at pharma companies and API manufacturers.