• What is impurity • Why should we control impurity • Understanding impurities • Sources of impurities • Presentation of impurities in your dossier More
Impurities in drug substances – ICH explained is a small book created to understand the impurities and how to present them in the dossier without heating your brain! This book is for the people who are studying pharmacy, chemistry, biochemistry, medicine, regulatory scientists and other beginners and professionals in pharmaceuticals. This book exclusively concentrates on ICH guideline ICH Q3A – impurities in new drug substances developed by a council consists of USA, Europe and Japan to have harmonized information for submission of common technical document/dossier. This guideline is adopted by various other countries like India, Australia, Canada, Afghanistan, Albania, Algeria and many… Rather than saying this as a small book, I would say this piece as instruction and template to write the impurity section in your drug substance dossier. In the future, all the topics covered by the ICH will be published in a much understandable and easy way with which you can quench your thirst on regulatory affairs and on quality.
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