Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

EDQM Explains How ICH's Elemental Impurities Guideline Will Apply To CEPs

Executive Summary

The European Directorate for the Quality of Medicines & HealthCare has issued guidance explaining the information that should be included in applications for certificates of suitability in the context of the international guideline on elemental impurities, ICH Q3D.


Related Content

ICH Q3D Metal Impurities Guidance Issued By FDA, EMA, Health Canada