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Many readers will be aware of the risk posed by nitrosamine impurities, as an ongoing pharmaceutical industry hot topic. In July 2021 ANVISA published their guidance for assessment and control of potentially carcinogenic nitrosamines in active pharmaceutical ingredients and drug products. To discuss this topic, we invited knowledgeable speakers from ANVISA, Industry - GSK and Libbs Farmacêutica - and Lhasa to give their perspectives on this topic. This article details the top 20 take away points from the workshop for quick and easy consumption - enjoy!

Coronaviruses are a large family of viruses which can affect humans or other species and can range anywhere from a mild illness such as the common cold to more severe illnesses such as Severe Acute Respiratory Syndrome (SARS). Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The recent discovery of N-nitrosamine (nitrosamine) impurities in several marketed pharmaceuticals has led to a requirement for further investigation into nitrosamine mutagenic and carcinogenic activity. Regulatory requirements mean that marketing authorisation holders for human medicines, containing chemically synthesised active substances, must review their medicines for the possible presence of nitrosamines and test all products at risk. Risk-based approaches to prioritise evaluations and subsequent confirmatory testing may be used. These assessments must be completed by October 2020, generating a significant challenge for the pharmaceutical industry.

Throughout the history of science, progression has relied upon the generation of new knowledge and  then building on that knowledge in order to gain even greater insight. In order to progress, this knowledge needs to be shared as widely as possible.

Lhasa Limited has been an advocate of data sharing for many years. In this piece, we explore the top 5 benefits of data sharing with Vitic.

Lhasa Limited, in collaboration with Leadscope, Inc., are leading a working group of pharmaceutical toxicologists and consultants investigating the carcinogenic potency and structure-activity relationships of N-nitrosamines.