Elemental impurities risk assessment is a critical activity mandated by regulatory bodies. International Conference of Harmonization (ICH) developed its guideline for elemental impurities, such as the Q3D and ICH Q9 - which is a risk-based quality control strategy. The elemental impurities in the drug products could affect the stability and efficacy of the finished product. Drug impurities can also have a hazardous effect on patients, and therefore must be monitored and controlled during the entire manufacturing process.
The need to create a uniform approach to assess elemental impurities was to minimize toxicological effects and to create global standards in drug manufacturing. For centuries, pharmaceutical industries were using manual or simple laboratory instruments and methods to calculate elemental impurities. These tests were not advanced enough to provide detailed analysis of the impurities. However, with the advancement in technology, toxicology assessment from excipients and application program interfaces (APIs) have become easier and accurate. Infosys has a strong understanding of the regulation processes around elemental impurities, and can work with pharma companies to meet regulatory standards.