To ensure the safety of the U.S. drug supply, FDA has launched the availability of a guidance for industry, entitled“Control of N-Nitrosamine Impurities in Human Drugs.” This guidance recommends steps manufacturers of activepharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamineimpurities in pharmaceutical products. The guidance also describes root causes that may introduce nitrosamineimpurities.Regulatory agency such as Health Canada has also identified potential root causes and have asked all pharmacompanies to review their manufacturing processes and controls, take action to avoid nitrosamine impurities in allmedications, as necessary, test any products that could potentially contain nitrosamine impurities and report theirfindings to Health Canada. They have also asked to perform risk assessment for potential drugs which can formnitrosamine impurities and a ect patient safety. Similarly, ANVISA also published regulations which provides forinvestigation, control, and elimination of potentially carcinogenic nitrosamines in angiotensin II receptor antagonists.Companies are required to have appropriate control strategies to prevent or limit the presence of these impurities and,where necessary, to improve their manufacturing processes. The 2nd edition of Nitrosamine Impurities Forum willdiscuss on the current challenges & future perspective to deal with these impurities in drug substances & drugproducts.
During these 2-days of the conference challenges such as chemistry behind formation of these impurities in API &drug products (b)matching regulatory expectations to combat these impurities (c) understanding different rootcauses of these impurities (d) implementing 3-stage risk assessment process(e)selecting appropriate testingmethod/equipment will be discussed by industry stalwarts.