calidad

Extractables and Leachables: Toxicological Evaluation and Risk Analysis

This course presents the general regulations, requirements of health agencies and expert panels regarding the analysis and identification of extractable and leachable impurities.

*IVA incluido

Advanced

1 hour

Course Description

The presence of impurities in drugs can be originated from primary and secondary packaging materials.

This is what you are going to learn!

This course presents the general regulations, requirements of health agencies and expert panels regarding the analysis and identification of extractables/leachables from packaging materials, how the toxicological evaluation of extractables/leachables impurities is performed and determination of toxicological limits, as well as toxicological risk analysis. Several case studies are also presented.
This course is mainly addressed to the pharmaceutical industry professionals from 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:
  • Knowing the concept of extractable/leachable impurities
  • Having a general knowledge of the plastic and glass materials most commonly used in the industry
  • Learning the regulations applicable to the regulation of extractables and leachables
  • Knowing how experimental studies are carried out and the parameters considered
  • Learning the concept of AET (Analytical Evaluation Threshold) and SCT (Safety Concern Threshold), as well as how to calculate the former
  • Identifying how toxicological evaluations of this type of impurities are performed
  • Learning how to calculate and establish toxicological limits and specifications
  • Applying what has been learned in practical cases that have been developed

Course contents