Nitrosamines: quick mobilization of a multidisciplinary team in response to regulatory changes

In June 2018, European authorities were informed by a pharmaceutical asset manufacturer of the presence of a nitrosamine in the active ingredient valsartan (sartan chemical family). Subsequently, other types of nitrosamines were detected by other manufacturers of sartans. These nitrosamines were already known to be probable carcinogenic compounds, but their presence in sartans was not identified at the time.

In September 2019, the European Medicines Agency (EMA), followed quickly by other authorities (Canada, United States …), asked, as a precautionary measure, all manufacturers of medicines for human use containing a synthetic active ingredient to check the potential contamination of their products by these nitrosamines.

These registrants were required to ensure that they had the necessary information to fully assess the potential presence of nitrosamines, including from their suppliers of active ingredients or raw materials.

Seqens, a major player in pharmaceutical synthesis and committed to the compliance of its processes and products, immediately mobilized to meet this requirement. Within a few weeks, Seqens set up a multidisciplinary task force (R&D, processes, Quality Assurance, purchasing, maintenance, etc.) at its 16 chemical and pharmaceutical production sites and at the Seqens’ Lab in Porcheville. This taskforce has set up a common strategy to assess the risk of nitrosamines in all the group’s products by evaluating the raw materials, the process and all the potential risk factors and by carrying out the necessary analyses on the products.

Nearly 250 products were reviewed by the teams. Clients were regularly informed of the progress of the study and the conclusions concerning the products related to them, so that they could meet their obligations. This work has been audited by the clients and inspected by the health authorities and has been satisfactory. To date, no risk of the presence of nitrosamine has been identified in the products of the Seqens Group.

Seqens remains committed to continuously assessing regulatory changes and mobilizing its network of experts to meet the needs of its customers.