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.
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