Guideline Specifications
Found 3 free book(s)
Q 3 B (R2) Impurities in New Drug Products
www.ema.europa.euICH Q6A guideline on specifications). Impurities arising from excipients present in the new drug product or extracted or leached from the container closure system are not covered by this guideline. This guideline also does not apply to new drug products used during the clinical research stages of development. The
European Medicines Agency
www.ema.europa.euThis guideline addresses specifications, i.e., those tests, procedures, and acceptance criteria which play a major role in assuring the quality of the new drug substance and new drug product at release and during shelf life. Specifications are an important component of quality assurance, but are not its only component.
eHealth Network - European Commission
ec.europa.eueHealth Network 2 The eHealth Network is a voluntary network, set up under article 14 of Directive 2011/24/EU. It provides a platform of Member States' …