ISO 10993-18:2020 outlines the chemical characterisation tests that manufacturers must undertake to support the biological safety of their medical devices.
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SGS Life Sciences
We look at the challenges posed in regards to nitrosamine testing methodologies and the way in which to move forward to ensure safer drug products.
We offer high quality analytical testing solutions for pharmaceutical and biopharmaceutical products through all phases of drug development, from discovery through early development and commercialisation. Find out more in this guide…
The identification of N-nitrosodimethylamine (NDMA) in an active pharmaceutical ingredient (API) in 2018 not only led to regulatory warnings and product recalls, but wider recognition that pharmaceutical manufacturers should adopt a proactive approach to risk assessment and mitigation in relation to genotoxic contaminants.
Analytical procedures are necessary to develop products and manufacturing process, to measure critical quality attributes and to ensure the quality of final products.
Developing new vaccines to fight emerging diseases is an ongoing fight and ensuring they are pure is vital to patients’ health and safety.
In a consortium led by the Jenner Institute, Oxford University, SGS has joined forces with specialists in infectious diseases, research and innovation, and pharmaceuticals to rapidly develop, scale-up and produce a potential vaccine called ChAdOx1 nCov-19.
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.
SGS's Center of Excellence for biosafety can help contribute to the fight against coronavirus.
Why do E&L testing? Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging.
Mycoplasma are a form of bacteria that are characterized by the absence of a cell wall surrounding the cell membrane.
The US Food and Drug Administration (US FDA) defines complex generics as products having intricacy associated with an active pharmaceutical ingredient(s) (API), formulation process, route of delivery, or drug-device combination.
Most, if not all pharmaceutical companies will have experienced a product, that has been on the market for a long time, to suddenly and unexpectedly trigger a signal for an unknown substance in the quality control (QC) laboratory approval process.
Medicines are heavily regulated during development, manufacture and distribution.