{"id":411,"date":"2024-04-25T12:03:45","date_gmt":"2024-04-25T12:03:45","guid":{"rendered":"http:\/\/annualreport.edqm.eu\/?page_id=411"},"modified":"2024-06-10T20:42:40","modified_gmt":"2024-06-10T20:42:40","slug":"response-to-nitrosamine-contamination","status":"publish","type":"page","link":"https:\/\/annualreport2023.edqm.eu\/en\/response-to-nitrosamine-contamination\/","title":{"rendered":"The EDQM\u2019s response to nitrosamine contamination | Quality & use of medicines"},"content":{"rendered":"\t\t
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Quality & use of medicines<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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The EDQM\u2019s response to nitrosamine contamination<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Certain types of nitrosamines, such as N<\/em>-nitrosodiethylamine (NDEA) and N<\/em>-nitrosodimethylamine (NDMA), are known as possible carcinogens for humans and only very low amounts are acceptable according to current regulatory requirements. Since their detection in a number of active substances in 2018, the EDQM has been working actively at various levels to address this issue, co-operating continually with regulatory authorities at international and EU level. Full information on this matter can be found on the EDQM\u2019s dedicated web page<\/a><\/span>.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Ph. Eur. strategy<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The European Pharmacopoeia Commission (EPC) continued to roll out its comprehensive nitrosamines action plan in 2023 after having adopted revised versions of two legally binding core general monographs, Substances for pharmaceutical use<\/em> (2034) <\/em>and Pharmaceutical preparations (2619)<\/em>, which now include a paragraph explaining the Ph.\u00a0Eur. approach to N<\/em>-nitrosamine impurities. This approach was defined based on the comments received on these texts during the last round of public consultation in Pharmeuropa<\/em>, together with recent feedback from the Heads of Medicine Agencies (HMA) and European Medicines Agency (EMA) groups and from the NCAs of non-EU Ph.\u00a0Eur. member states.<\/p>

The new paragraph, added to the Production section of each of these major texts, states that manufacturers are now expected to evaluate the potential risk of N-<\/em>nitrosamine formation and contamination occurring throughout their manufacturing process and during storage (2034<\/em>) or shelf life (2619<\/em>). If confirmed, manufacturers should mitigate as far as possible the risk of N-<\/em>nitrosamines being present \u2013 for example by modifying their manufacturing process \u2013 and implement a control strategy to detect and control them.<\/p>

The revised monographs were published in Ph.\u00a0Eur. Supplement 11.3 (July 2023) and implemented on 1 January 2024.<\/p>

Building on this, the next step in the action plan aimed at defining how to address the issue of nitrosamine control in individual monographs.<\/p>

After consulting its stakeholders over the course of 2023, the EPC approved the strategy for N<\/em>-nitrosamine impurities in individual monographs at its 177th session in November 2023. This strategy is detailed below.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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