Urgent ECA/APIC/European QP Association Meeting on Nitrosamine Impurities announced

In June 2018 EU authorities were notified about the presence of N-nitrosodimethylamine in Valsartan batches of a Chinese API manufacturer. Since then more and more cases of drug substance and drug product batches contaminated with Nitrosamines came to be known. Now all Marketing Authorization Holders are obligated to evaluate the risks of their products containing chemically synthesized APIs within a very short deadline.

To help you find out how you efficiently perform the requested risks assessments, the ECA together with APIC/CEFIC and the European QP Association have organized a 1-Day Urgent Compliance Meeting "Nitrosamine Impurities" on 18 February 2020 in Frankfurt. In addition you will learn there,

  • what you need to take into account when risks have to be evaluated,
  • how you mitigate the risks of Nitrosamine contamination through supply chain oversight,
  • how suppliers of raw materials, solvents and packaging materials should be qualified,
  • which regulatory actions you need to take in case of changes related to processes, suppliers, raw materials etc.
  • how Marketing Authorisation Holders, API manufacturers, drug product manufacturers and author-ities should communicate and cooperate.

During this meeting you will also benefit from tools and aids you will receive - like decision trees or templates for risk assessments.

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