After the initial discovery of nitrosamine impurities in drugs and Active Pharmaceutical Ingredients (APIs) by the USFDA in mid-2018, the EU Regulatory bodies have also joined many other countries in a bid to prevent the risks involved. They have re-called several medicines that post health perils from the substance. Known for its carcinogenic properties, Nitrosamine may prove to be harmful when ingested above the accepted levels by humans. The substance, N-nitrosodimethylamine (NDMA), has an acceptable limit of 96 ng/day and anything above this is objectionable in drugs and APIs.
Health Based Exposure Limits (HBELs) - Regulatory Expectations and Challenges An Informative Webinar
Pharmaceutical companies sometimes manufacture the products using multipurpose manufacturing facilities to develop different medicinal products. Production at such facilities may create potential cross-contamination and pose a risk on products’ safety and efficacy. Hence, toxicological risk assessment is of utmost importance, to evaluate the possible risks of cross-contamination for medicinal products. The risk assessment is done by establishing a cleaning validation program, which comprises a scientifically based threshold value - Health Based Exposure Limit (HBEL).