Example: dental hygienist
Genotoxic Impurities
Found 2 free book(s)Q&A on the CHMP Guideline on the Limits of Genotoxic ...
www.ema.europa.eupotentially genotoxic impurities or to higher levels of previously recognized potentially genotoxic impurities then the situation should be discussed with the competent authority. Question 9. What is a reasonable policy for setting specifications for potentially genotoxic
Q3C (R5) Impurities: guideline for residual solvents
www.tga.gov.auqualification of impurities as expressed in the guideline for drug substance (Q3A, Impurities in New Drug Substances) or drug product (Q3B, ... Non-genotoxic animal carcinogens or possible causative agents of other irreversible toxicity such as neurotoxicity or teratogenicity.