Pre-Conference Session APIC/CEFIC Conference: Nitrosamine Impurities - GMP and Regulatory requirements

During this pre-Conference Session you will hear an update on how to deal with Nitrosamine Impurities from a GMP perspective and how to handle cases of Nitrosamine contamination in terms of filing changes/variations. You will get to know

You will receive first hand information from speakers representing  the European QP Association and APIC.

 

This pre-conference session ideally complements the following 23rd APIC/CEFIC Global GMP & Regulatory API Conference.

In June 2018 EU authorities were notified that a Chinese API manufacturer has detected the presence of N-nitrosodimethylamine, NDMA, in batches of Valsartan. NDMA is known to be genotoxic and carcinogenic and is classified as a Class 2A carcinogen to humans. After a referral under Article 31 of Directive 2001/83/EC the CHMP assessed the impact of the presence of this impurity on the benefit-risk balance of valsartan-containing drug products and issued a recommendation whether the concerning marketing authorisations can still be maintained or should be suspended.

 

Meanwhile, different Nitrosamines (NDMA, NDEA and others) were detected in almost every drug product which contains a sartan derivative as an API. Marketing Authorisation Holders have been requested to evaluate the risk of the presence of Nitrosamine impurities in human medicinal products containing chemically synthesised APIs.