SGS

To support the growing need for nitrosamine testing, SGS has expanded its volume for nitrosamine testing beyond its current service offering in Mississauga, Canada. SGS has added capacity and instrumentation to offer nitrosamine testing, including drug substance-related impurities (NDSRIs) at its West Chester, PA and Markham, Canada laboratories to allow for expanded capacity for nitrosamine testing, while staying ahead of the curve as regulations continue to evolve.

To support the growing need for nitrosamine testing, SGS has expanded its volume for nitrosamine testing beyond its current service offering in Mississauga, Canada. SGS has added capacity and instrumentation to offer nitrosamine testing, including drug substance-related impurities (NDSRIs) at its West Chester, PA and Markham, Canada laboratories to allow for expanded capacity for nitrosamine testing, while staying ahead of the curve as regulations continue to evolve.

There has been a Growing concern among regulators driving a need for awareness for manufacturers to understand the risk associated with nitrosamines in pharmaceutical and biopharmaceutical products. In this session of Changing the Conversation with SGS Live, we tackled a variety of aspects of this important issue from the risk associated with nitrosamine contamination to discovery and mitigation of nitrosamine impurities. Our experts shared the current testing requirements, along with how SGS is helping drug manufacturers along the path of development to ensure their products are free from nitrosamine contamination.

This article provides an assessment of nitrosamine contamination specifically in biologics and contrasts the potential risks between these product types.

SGS has developed a network of centers of excellence for Nitrosamine testing across all regions to better serve our clients. Our experts specialize in method development solutions to identify and quantify all nitrosamine contaminants, including the challenging nitrosamine drug substance related impurities (NDSRIs).

This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.

Coupling a headspace sampling technique with a HRAM GC-MS system provides quick assessments and quantifies potentially dangerous, untargeted volatile extractables

Detection of N-Nitrosodimethylamine (NDMA) impurities has led to regulatory warnings and product recalls. Pharmaceutical manufacturers must adopt a proactive approach to risk assessment and mitigation in relation to genotoxic contaminants.

Join experts from SGS and Thermo Fisher Scientific to hear how to improve workflows for confident extractable and leachable studies. Live: North America: Tuesday, Oct. 31, 2017 | 11am EDT | 10am CDT / Europe: Tuesday, 7 Nov., 2017 | 9am GMT | 10am CET / On Demand available after airing until 7 Nov., 2018. Register free: http://www.pharmtech.com/pt_w/analytical