The pharmaceutical industry is currently facing stringent new demands on elemental impurities from regulators stipulating the control and documentation of elemental impurities in drug products, drug substances and excipients. In response to these demands, Almac Group has announced significant investment in a state-of-the-art elemental impurities analysis laboratory at their European Headquarters, Craigavon, UK.
In compliance with USP <232 & 233>, EP (2.4.20) and ICH Q3D, all components, processes, packaging and final product must be risk assessed or tested for the presence of elemental impurities. Inductively coupled plasma mass spectrometry (ICP-MS) is widely recognised as the most suitable technique to meet the requirements of these, and future, regulatory requirements.
The new temperature controlled laboratory will incorporate industry-leading ICP-MS instruments; Thermo iCAP RQ C2 and Agilent 7900, in addition to MARS 5 and 6 microwave digesters. This investment enhances the existing well-established Almac ICP-MS testing service already available to clients.
Almac’s dedicated elemental impurities analysis team has already worked with many pharmaceutical companies to address the challenges of these new regulatory guidelines. A recent example was published in the Journal of Pharmaceutical and Biomedical Analysis: “Development and validation of an ICP-MS method for the determination of elemental impurities in TP-6076 active pharmaceutical ingredient (API) according to USP232/233” vol. 145, pp. 84–90, Oct. 2017.
“With this investment, we are in a position to fully support our global clients in both the pharmaceutical and biopharmaceutical sectors through the challenges of these new regulatory guidelines,” commented Dr Osama Chahrour, Leader of ICP-MS Services, Almac Sciences.
“Almac continues to invest heavily in state-of-the-art instruments and laboratories to meet the challenges of new regulations. This enables us to focus on fully supporting our clients through their drug development programs,” added Dr John Malone, Analytical Manager, Almac Sciences.