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Nitrosamine Detection: Meet EMA and FDA Regulations

Lab Services News for Bio Pharmaceuticals Quality Control Testing26 Mar 2020

In 2018, the presence of the nitrosamine N-nitrosodimethylamine (NDMA), a potential carcinogen, in certain sartan active pharmaceutical ingredients (APIs) resulted in several regulatory warnings and recalls of contaminated products.

Concerns over the presence of this class of genotoxins has since widened to include other medicines, such as the well-known diabetes drug Metformin, and Ranitidine, which is used to treat heartburn and stomach ulcers.

In September 2019, the EMA and other regulatory authorities instructed all pharmaceutical manufacturers to conduct a risk assessment and proactively test their products to protect patients and ensure that effective measures are taken to prevent the presence of nitrosamine impurities in human medicines by the end of March 2020.

Marketing authorization holders will then have until September 26, 2022 to perform further confirmatory testing on the products identified to be at risk of N-nitrosamine formation or (cross-)contamination and take mitigation measures where risks are identified, starting with the highest risk products.

SGS has developed a test method to identify nitrosamine impurities in drug products to help drug sponsors ensure product safety. The test method, based on LC-MS, detects the presence of NDMA traces in drug products, raw materials and APIs, at even the lowest levels. Central to these activities is a coordinated analytical capability to identify and quantify contaminants across global geographies and regulatory zones.

Available globally, through a global network of Life Sciences testing laboratories, our test method will:

  • Identify NDMA traces in drug products, raw materials and APIs
  • Protect patients
  • Ensure regulatory compliance

We offer our expertise to help you assure the safety of your drug products, verify their status and protect your patients. With fast turnaround times and the most effective test method currently on the market, you can trust SGS to quickly and efficiently identify any issues, so you can take remedial action swiftly.

SGS leverages its digitalized network of Life Sciences laboratories, present in North America, Europe, and Asia-Pacific, to deliver harmonized testing solutions for analytical development, biologics characterization, biosafety and quality control, as well as clinical research to large pharmaceutical and biotechnology firms.

For further information, please contact:

Mark Rogers
Global Scientific Director, SGS
t: +1 215 356 2336

About SGS

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 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

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