SGS expands elemental impurity testing services

Company has successfully developed and validated impurity test methods in line with ICH Q3D regulatory guidelines.

ICH Q3D Step 4 was published in December 2014. Since then, it has required that a risk analysis be deployed for all drug products on the specified list of elements and their permitted daily exposure (PDE) limits. The guideline came into effect in June 2016 for new drug products, and existing products needed to comply by December 2017. Using Agilent 7700 and 7800 ICP-MS systems, SGS’s laboratory in Chennai has now successfully developed and validated impurity test methods in line with ICH Q3D.

Chennai now joins a number of the laboratories across Europe and North America within the SGS laboratory network to offer elemental impurity testing for pharmaceutical products, and providing local support to drug developers.

“SGS has a well-trained and qualified elemental impurities team in Chennai that can effectively support pharmaceutical and biopharmaceutical companies in the South East Asia region, in accordance with the ICH 3QD guidelines,” commented Sathananthan Sangaran, National Operations Director of India. He added: “On a global level, SGS is fully committed to offering its clients access to the very latest technology and expertise to ensure regulatory demands can be met efficiently.”

The 1,850-m2 Chennai laboratory was opened in 2005 and has strong capabilities in method development and validation analytical chemistry as well as batch release, utilities qualification and monitoring; healthcare product and healthcare supplement testing; microbiological testing; safety and stability studies.