Evaluation of Elemental Impurities in Drugs and Drug Products ICH Q3D(R2)
Автор: Hitendrakumar Shah
Загружено: 2024-07-20
Просмотров: 4386
This training session will focus on Evaluation of Elemental Impurities in Drugs and Drug Products in line with the guideline ICH Q3D(R2). Specifically will help you understand about practical implementation with compliance approach towards the Evaluation of Elemental Impurities in Drugs and Drug Products.
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. There are three parts of this evaluation as per the guideline:
1. The evaluation of the toxicity data for potential elemental impurities;
2. The establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern; and
3. Application of a risk-based approach to control elemental impurities in drug products.
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