Safety is one of the key quality attributes in pharmaceutical products, therefore, impurity levels need to be controlled in order to meet the regulatory requirements. Especially biological products, which require a complex production process and involvement of a broad range of chemicals, and impurities both adventitious and endogenous are concerned. Controlling the impurity level in the raw material and aggregate management are 2 strategies that can be considered. The session will brief you through an elemental impurity as per ICH Q3D, a Risk-based Approach to Evaluate Nitrosamines as well as Impurity removal in Biologics as an aggregate management.

to learn about these topics
1. Guideline on Elemental Impurities, Nitrosamines, EG and DEG for Formulation Material
2. Raw Material Selection in Pharmaceutical and Biopharmaceuticals Amid Impurities and Formulation Challenges
3. Impurity removal in Biologics: Aggregate management
4. Impurity in Biological products

impurity, nitrosamines, Biological products

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