ABSTRACT
With the discovery of carcinogenic nitrosamine impurities in pharmaceuticals in 2018 and subsequent regulatory requirements for risk assessment for nitrosamine formation during pharmaceutical manufacturing processes, storage or from contaminated supply chains, effective testing of nitrosamines has become essential to ensure the quality of drug substances and products. Mass spectrometry has been widely applied to detect and quantify trace amounts of nitrosamines in pharmaceuticals. As part of an effort by regulatory authorities to assess the measurement variation in the determination of nitrosamines, an inter-laboratory study was performed by the laboratories from six regulatory agencies with each of the participants using their own analytical procedures to determine the amounts of nitrosamines in a set of identical samples. The results demonstrated that accurate and precise quantitation of trace level nitrosamines can be achieved across multiple analytical procedures and provided insight into the performance characteristics of mass spectrometry-based analytical procedures in terms of accuracy, repeatability and reproducibility.
Subject(s)
Nitrosamines , Humans , Nitrosamines/analysis , Reproducibility of Results , Mass Spectrometry , Pharmaceutical PreparationsABSTRACT
Official medicines control laboratories (OMCLs) have for a long time been involved in testing activities related to suspected counterfeit or other illegal medicines in a number of European countries in support of national enforcement authorities. With the secretarial support of the European Directorate for the Quality of Medicines & HealthCare (EDQM), from 2005 onwards, the General European OMCL Network (GEON) has gradually introduced for its members tailored tools, joint test programmes and information/discussion platforms in the field of falsified medicines testing. Since 2011 a dedicated OMCL working group (OMCL Counterfeit/Illegal Medicines Working Group) has taken the lead in coordinating the different activities, which range from training programmes, symposia and focus topics at annual meetings to the development and improvement of databases and the drafting of common documents. The overall goal of these activities is to share know-how, to establish and identify centres of expertise, to further develop competencies in the field of analysis of falsified medicines, to challenge the competency of OMCLs in the testing of unknown samples, to raise awareness of the network and to leverage synergies in particular with respect to this field of expertise. All these measures aim at strengthening the network in the combat against falsified medicines, enlarging the field of activities of the OMCLs in this area and improving the hit rate with respect to the identification of adulterations.