SGS, the analytical and bioanalytical contract solutions provider with a global footprint, has expanded elemental analysis testing capabilities at its laboratory in Chennai, India. The site now operates three inductively coupled plasma mass spectrometry (ICP-MS) systems.
The investment aims to address the updated ICH Q3D regulatory guidelines on elemental impurities and establish a South East Asia Center of Excellence for elemental analysis.
“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.”
Chennai now joins several labs 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
Compliance with regulatory guidance
The ICH Q3D Step 4, published in December 2014, 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; existing products needed to comply by December 2017.
Using Agilent 7700 and 7800 ICP-MS systems, SGS’s laboratory in Chennai has now developed and validated impurity test methods in line with ICH Q3D.
Chennai now joins several labs 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.
The 1,850sqm 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) modelling and simulation, pharmacovigilance and regulatory consultancy.