calidad

Evaluation of Elemental Impurities (ICH Q3D)

In this course we will explain the European and American Regulation, the potential elemental impurities sources and their evaluation.

Leticia Sanz
Area Responsible
leticia.sanz@azierta.com

Advanced

1 hour

Course Description

Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present as impurities (e.g., through interactions with processing equipment or container/closure systems or by being present in components of the drug product). Because elemental impurities do not provide any therapeutic benefit to the patient, their levels in the drug product should be controlled within acceptable limits.

This is what you are going to learn!

In this course we will explain the European and American Regulation, the potential elemental impurities sources and their evaluation, as well as the control limits.
The course is addressed to Quality Assurance department, and workers associated to the manufacturing process.

Main Objectives

The most important objectives to be achieved with the progress of the course are listed below:
  • Knowing what and which elemental impurities are included in the guideline. 
  • Differentiate between the obsolete heavy metals test and the ICH Q3D methods and analysis for elemental impurities. 
  • Knowing the classification of impurities according to toxicity, route of administration and probability of occurrence. 
  • Learning the steps to be followed in risk analysis. 
  • Identifying the sources of contamination of elemental impurities during the whole manufacturing process of the product. 
  • Analysing and developing the different sources of contamination identified. 
  • Understanding the different options for evaluation of elemental impurities and their acceptable levels with respect to the EDP of the route of administration. 
  • Knowing all the necessary documentation to be assessed during the risk analysis.

Course contents