|Download document||Draft guideline on assessment and control of DNA reactive, mutagenic impurities in veterinary medicines|
|Status||draft: consultation open|
|Consultation start date||2017-02-24|
|Consultation end date||2017-08-31|
|Email address for firstname.lastname@example.org|
This guideline focuses on deoxyribonucleic acid (DNA) reactive substances that can potentially cause DNA damage when present at low levels leading to mutations and therefore, potentially causing cancer. Its purpose is to provide a practical framework for identifying, categorising, qualifying and controlling these mutagenic impurities to limit any potential carcinogenic risk. It considers both safety and quality risk management measures to establish levels of impurities with a negligible carcinogenic risk.