9/10 November 2023
At its 174th meeting in November 2022, the European Pharmacopoeia Commission adopted the two revised general monographs Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619). Based on the comments received during the last consultation session in Pharmeuropa, the two monographs were each extended by a section containing requirements with regard to possible contamination by nitrosamines.
According to this, manufacturers of APIs must observe the following requirements:
These core requirements are supplemented in the section of the monograph Pharmaceutical preparations (2619) by the restriction that these requirements do not apply to manufacturers of veterinary medicinal products and unlicensed products ("... manufacturers of medicinal products, except products for veterinary use only and unlicensed pharmaceutical preparations...") and that the risk assessment must consider the entire shelf life of the product as required by the regulatory authorities.
The revised monographs will appear in Supplement 11.3 of the European Pharmacopoeia in July 2023 (see Ph. Eur. Publication schedule) and will apply as of 1 January 2024.
Further information on nitrosamine contamination can be found on the EDQM website in the section entitled N-nitrosamin contamination in brief.