www.api-conference.org

Related Information

The videos on this webpage provide additional information from regulatory authorities such as FDA and ICH.

 

Overview of the FDA Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs

On September 2, 2020, FDA published a guidance for industry entitled Control of Nitrosamine Impurities in Human Drugs. In this Video published by FDA on October 2nd 2020, the FDA explains the guidance recommendations and industry expectations related to the steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. Additionally, FDA reviews the conditions that may introduce nitrosamine impurities and the need for a risk assessment strategy for potential nitrosamines in any pharmaceutical product at risk for their presence.

 

ICH Q11 Selection and Justification of Starting Materials – Video Training

The ICH published a video on ICH Q11 Guideline on Development and Manufacture of Drug Substances and the related Q&As which have been published in 2018 for further clarification to promote convergence on the considerations for the selection and justification of starting materials.