On 6-7 November 2023 and 17-18 June 2024, two technical training sessions for OMCLs on the testing of nitrosamine contaminants were held at the Swissmedic OMCL in Bern. These were the first two hands-on training sessions focusing on the identification and quantification of this group of mutagenic impurities, organised in reaction to the nitrosamine incidents. 

The training programme provided a mixture of theoretical lectures and practical lab-based exercises in two separate groups and included a lab tour and the possibility for discussion and exchange of information and expertise between peers. Another objective of the training was to encourage OMCLs to buy new equipment allowing the analysis of nitrosamines and other toxic impurities at ppm and ppb level. The techniques presented during the training were: 

• GC-MS/MS, and
• LC MS/MS.

Twenty-one OMCL trainees from 16 member states followed the two courses, each lasting two full days. In addition to an introduction to the analytical procedures applied in the Swiss laboratory, the theoretical lectures covered topics such as the history of nitrosamine contamination cases in medicines, sample preparation and pitfalls and troubleshooting in nitrosamine analysis. Towards the end of the sessions, the participants were also given the opportunity to provide feedback to the organisers about the usefulness of the training. 

Hands-on training sessions have been offered to members of the OMCL Network since 2012. While the training programme initially focused exclusively on the testing of falsified medicines, it has recently been extended to include topics in the field of analysis of authorised medicines. This exercise is seen as a means of keeping the General European OMCL Network laboratories up to date with new analytical developments in the testing of medicines and to foster work-sharing and collaboration.