APIC Guidance on Nitrosamines Risk Assessment

APIC Guidance on Nitrosamines Risk Assessment

Recently APIC (the association of manufacturers of European APIs) has published a complete guide to make the risk assessments of Nitrosamines.

Members of the Moehs Group have participated in the work team of this guide as experts for the elaboration of the contents: Helena Camps, Alicia Dobarro and Jordi Valls, on behalf of the Spanish Association of Fine Chemical Products Manufacturers (AFAQUIM).

The EMA and other Health authorities have published requirements (EMA/189634/2019 – Information on Nitrosamines for Marketing Authorization Holders) and Health Canada Letter (Health Canada – Information to Marketing Authorization Holders (MAH) of Human Pharmaceutical Products Regarding Nitrosamines Impurities, letter from October 2, 2019) for the API industry and the MAH for drug products to expand the scope of potential sources of nitrosamines beyond that of ICH M7 (Assessment and Control of the DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk). This requirement is based on the fact that, as the Industry and the authorities are gathering more information about the potential ingress / formation of such impurities in APIs, there is need to expand the evaluation of risk assessments that are needed to ensure APIs are fit for their intended use and do not pose a patient safety risk for such impurities. These requirements are new to the industry and as such APIC had devised this document to aid industry generating risk assessments as well as assistance on the level of information that is needed to be sent to the MAH for their overall drug product risk assessments.

APIC represents API producers and API intermediates in Europe.

A great job that will have an important job in the industry and for which we want to congratulate our colleagues.

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