How to know about ICH Guidelines in Telugu || ICH Guidelines in Pharma Industry || Pharma Guide

How to know about ICH Guidelines in Telugu || ICH Guidelines in Pharma Industry || Pharma Guide In this video we are discussing about ICH Guidelines. The International Conference on Hormonisation of techinical requirments for registration of pharmaceuticals for human use. Since its inception in 1990, ICH has gradually evolved to respond to the incresingly global face of drug development. The ICH guidelines are explained in 4 different topics, those are 1.Quality topics 2.Safety topics 3.Efficacy topics 4.Multi disciplinary topics. Hormonisation achievements in the quality area include pivotal milestsones such as the conduct of stability studies. In Quality topics, stability is one of the most important topic, in this 3 different types of stabilities are involved. Those are Long term stability, accelarated stability and intermediate stability. In this impurity testing 3 types of impurities are checked,those are Organic impurities, Inorganic impurities and Residual impurities. The ICH defining relevent thresholds for impurities testing and a more flexible approch to pharmaceutical quality based on GMP risk management. In this quality topics validation is play an important role. The systems and processes should be periodically evaluated to verify that they are still operating in valid manner. The safety topics of ICH has produced a comprehensive set of safety guidelines to uncover potential risks like carcinogenecity genotoxicity and reprotoxicity. The carcinogenesis means for transformation of normal cells to cancer cells. The Genotoxicity means for toxic effects of physical, chemical and biological agent on genetic material like DNA or RNA. The Reprotoxicity includes advers effects on sexual function and fertility in adult meles and females, as well as developmental toxicity in the offspring. #pharmaguideradhakrishna #PharmaGuide