В предыдущем посте я писала об изменениях в регистрационных досье на ЛП, связанных с обнаружением примесей N-нитрозаминов.
Этот пост посвящен изменениям в Европейской фармакопее.
В конце 2022 г. в раздел Production общих фармакопейных статей Евр. фарм. 2034 Substances for pharmaceutical use и 2619 Pharmaceutical preparations добавлено следующее положение:
“N-Nitrosamines. As many N-nitrosamines are classified as probable human carcinogens, manufacturers of active substances for human use are expected to evaluate the potential risk of N-nitrosamine formation and contamination occurring throughout their manufacturing process and during storage. If the risk is confirmed, manufacturers should mitigate as much as possible the presence of N-nitrosamines – for example by modifying the manufacturing process – and a control strategy should be implemented to detect and control these impurities. General chapter 2.5.42 N-Nitrosamines in active substances is available to assist manufacturers.”
Разработана отдельная фармстатья: Ph. Eur. 2.5.42. N-Nitrosamines in active substances.
Привожу отдельным постом.↓↓↓
