Almac helps clients meet FDA heavy metal mandates

As the industry faces tight new heavy metal mandates from the FDA, stipulating the control and documentation of elemental impurities in drug products, drug substances and excipients, Almac has invested in ICP-MS equipment at its European headquarters, Craigavon, to future-proof clients’ drug development programs to satisfy these new regulations.

In compliance with USP <232 & 233>, EP (2.4.20), and ICH Q3D, all components, processes, packaging and final product  must be tested for the presence of heavy metals, and inductively coupled plasma mass spectrometry (ICP-MS) is the most suitable technique to meet the requirements of these, and future regulatory requirements.

To prepare for current and future implications of these mandates, Almac has expanded its mass spectrometry capabilities, investing in the Agilent 7900 ICP-MS and Mars microwave digestion technology. 

Linda McCausland, head of Almac’s physical sciences and spectroscopy stated: “These mandates dictate a significant shift in the attitude of the FDA towards heavy metals in all aspects of drug development. Customer focus is our top priority, and the enhanced services offered from this additional investment will provide assurance for our clients whilst complying with the regulatory guidelines.”

Stephen Barr, managing director of Almac Sciences added: “We are delighted we can support our customers through the challenges of the FDA’s stringent new mandates for heavy metal analysis. This investment reinforces our commitment to fully support our clients through every aspect of their drug development programs.”