With the first deadline for the ICH Q3D guideline on elemental impurities just a few weeks away, pharma companies are still facing some uncertainty about how to comply with the requirements. 

After June of this year, any pharma company in ICH regions wishing to file a marketing application for a drug will have to comply with the guidance, while established products will have to be ICH Q3D-ready by December 2017. In essence, ICH Q3D introduces a risk-based approach to the control of elemental impurities in the finished dosage form, taking into account potential sources such as the active pharma ingredient (API), excipients, manufacturing equipment, processing aids such as catalysts or water and container closure systems.

By Phil Taylor, 09-Mar-2016

More