About this document
Nitrosamine Impurities Q&A for MAHs by Thamara de Carvalho is a document available to read on EtoBox.
The document provides questions and answers for marketing authorization holders and applicants regarding the CHMP opinion on the Article 5(3) referral on nitrosamine impurities in human medicines. It addresses topics such as risk evaluation, confirmatory testing, analytical methods, action limits, and regulatory requirements.
- Author
- Thamara de Carvalho
- Language
- EN