Elemental Impurities: Implications for Manufacturers of Drug Products, APIs & Excipients

Introduction

The International Conference on Harmonization (ICH) finalized the ICH Q3D Guideline for elemental impurities in December 2014.1 Regulators are now implementing the requirements worldwide, with some start dates already in place as of June 2016. 

ICH Q3D is the most comprehensive guideline for limits and risk assessment approaches for elemental impurities in final drug products to date; however, it does not specify limit for the major components of drug products. This brings excipients in particular under scrutiny, being they, unlike APIs, lack established daily doses.2 Given this, how can drug product manufacturers assess risk of elemental impurity to comply with ICH Q3D?

See more at 

Download
Elemental Impurities: Implications for Manufacturers of Drug Products, APIs & Excipients
By: Ulrich Reichert, PhD, Head of Pharma & Food Materials, Regulatory Management, Merck KGaA, Darmstadt, Germany
Drug Development & Delivery: Issue: January/February 2017, Posted Date: 1/13/2017
Elemental Impurities: Implications for M
Adobe Acrobat Document 1.8 MB