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This article is the second of three in a series focused on regulatory management of impurities in drug substances and drug products from a regulatory chemistry, manufacturing, and controls (CMC) perspective. The first article examines the main international guidelines related to impurities, and this article outlines a risk-based approach for regulatory management of impurities. The third and final article will present simulated case studies for impurities management in drug substances and drug products.

This is the fourth and final article in a series exploring the topic of impurities in both drug substances and drug products from a regulatory chemistry, manufacturing, and controls (CMC) perspective. It presents a simulated case study for the management of drug product impurities. The other articles in this series focus on the main international guidelines, considerations for a risk-based assessment approach to regulatory management of impurities, and a simulated case study for impurities management in drug substances.

This article is the third in a series focused on regulatory management of impurities, introducing the topic of impurities in both drug substances and drug products from a regulatory CMC perspective. It presents a simulated case study for the management of drug substance impurities. The other articles in this series focus on the main international guidelines, considerations for management of impurities according to a risk-based approach, and a simulated case study for impurities management in a drug product.

This article is the first of a series focused on regulatory management of impurities, introducing the topic of impurities in both drug substances and drug products from a regulatory chemistry, manufacturing, and controls (CMC) perspective. In this article, the main international guidelines, with a specific focus on mutagenic, nitrosamine, and elemental impurities, are discussed. Risk-based approaches for regulatory management of impurities and simulated case studies for impurity management in drug substances and drug products are discussed in the subsequent articles of the series, published separately.