A BRIEF REVIEW ON NITROSAMINE FOOTPRINTS IN PHARMACEUTICAL INDUSTRIAL LAYOUT

Nitrosamines impurities are highly mutagenic which are generally produced from the chemical reactions between amino groups like secondary amines and tertiary amines and nitro sating agents prominently. Nitrosamines production depends on the environment, storage factors like pH, temperature etc.., these may get developed while preproduction, intermediate processing and post production also, mostly from the excipients, raw materials used in the production process. In this review, an industrial layout was explained briefly from the initial step of procurement of required materials from the market to the end sale of the product into the market. Industrial layout includes the warehousing areas, manufacturing areas, packaging areas and storage areas. Quality checking documentation for the nitrosamine’s traces are recommended for the approval from regulatory authorities, explaining the details of cross contamination, quality testings, factors affecting during production and finally the new methods and basic steps should follow to manage the cross contamination and risk management approaches to ensure the quality. Manufacturing steps like mixing, grinding, compression/ punching, filling, packaging etc… are involved in nitrosamine contamination risks, packaging materials are also responsible for the nitrosamine’s contamination. Waste water containing nitrosamine is treated over for the environmental quality management. Minimizing the risk of contamination ensuring the safety, quality, of the product by adapting the mitigation strategies. Keywords: Nitrosamine impurities; Excipients; Quality risk management; Industrial layout; Cross contamination.