Toxicological Evaluation and Characterization of Organic Impurities

Understand the applicable regulations and how toxicological evaluations of organic impurities are performed in the drug manufacturing process.
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1 hour

Course Description

The presence of off-spec organic impurities in medicines can have an impact on patients' health and consequences such as the withdrawal of batches from the market.

This is what you are going to learn!

This course presents the regulations applicable to this type of impurities (ICHQ3A, ICHQ3B, EMA draft of non-genotoxic impurities and ICH M7), how the toxicological evaluation of these impurities is performed and how the limits are established. Several case studies are also presented.
Mainly aimed at pharmaceutical industry professionals in Quality Assurance, Quality Check, as well as those involved in Regulatory Affairs, R&D and Pharmaceutical Development.

Main Objectives

The most important objectives to be achieved with the progress of the course are listed below:
  • Learning the concept of impurity
  • Knowing the regulations applicable to the regulation of impurities in active substances and pharmaceutical products
  • Understanding the different general limits applicable to impurities and the decision trees according to the guidelines
  • Knowing the QSAR methodologies applied to toxicological evaluations
  • Learning how to calculate and establish toxicological limits and specifications
  • Applying what has been learned in practical cases that have been developed

Course contents

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