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23

Gen

Ph. Eur. adopts revised general monographs after adding paragraph on N-nitrosamines

The European Pharmacopoeia (Ph. Eur.) Commission (EPC) adopted the revised general monographs 2034 and 2619, at its 174th session in November 2022which now includes a paragraph explaining the Ph. Eur. approach to the control of N-nitrosamine impurities.

A paragraph on N-nitrosamines has been added to Substances for pharmaceutical use (2034) under ‘Production’:

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.”

A similar paragraph on N-nitrosamines has been added to the same section in Pharmaceutical preparations (2619):

N-Nitrosamines. As many N-nitrosamines are classified as probable human carcinogens, manufacturers of medicinal products, except products for veterinary use only and unlicensed pharmaceutical preparations, are expected to evaluate the potential risk of N-nitrosamine formation and contamination occurring throughout their manufacturing process and throughout their shelf-life, according to the requirements of the relevant competent authorities. 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 must be implemented to detect and control these impurities. General chapter 2.5.42. N-Nitrosamines in active substances is available to assist manufacturers.” [EDQM _ EPR]

01

Feb

FDA Updates Policy Manual on Voluntary Withdrawal of Approved ANDAs

The FDA has updated its Manual of Policies and Procedures (MAPP) concerning receiving and processing...

01

Feb

EMA update on shortages of antibiotics in the EU

EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met...

01

Feb

EMA pubblica la linea guida su classificazione dei medicinali veterinari ai fini della prescrizione

Il Comitato per i medicinali veterinari (CVMP) dell’EMA ha adottato la Guideline on the application...

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