The ICH Q3D regulatory guideline outlines the process to “assess and control” elemental impurities in a drug product using the ICH Q9 principles of quality risk management.
To address the guideline, SGS – which provides analytical and bioanalytical contract solutions – has expanded its elemental analysis testing capabilities at its laboratory in Chennai, India.
Three inductively coupled plasma mass spectrometry (ICP-MS) systems have been added at the site, which it also is establishing as a South East Asia Center of Excellence for elemental analysis.
The 1,850 square meter Chennai laboratory can now develop and validate impurity test methods in line with ICH Q3D using the Agilent 7700 and 7800 ICP-MS systems.
"Due to official implementation of this guideline [ICH Q3D], it became mandatory for all manufacturers of drug substance and drug products marketing their products in the US and EU to perform the elemental impurities analysis," said Sangaran.
Sangaran told us this has created a "huge requirement for elemental impurities analysis" for existing and new products.
"Manufacturers either did not have in-house capabilities or had small set ups which could not accommodate the testing of a large set of existing marketed products," he added.
