The site has invested in three inductively coupled plasma mass spectrometry (ICP-MS) systems, in a move to address the updated ICH Q3D regulatory guidelines on elemental impurities and establish a South East Asia Center of Excellence for elemental analysis.
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 for SGS in 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.
With 18 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned global network to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the biopharmaceutical market, SGS also provides Phase I-IV clinical trial management, and services encompassing data management and statistics, PK/PD (pharmacokinetic/pharmacodynamic) modeling and simulation, pharmacovigilance and regulatory consultancy.
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SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 95,000 employees, SGS operates a network of over 2,400 offices and laboratories around the world.