Stability Testing of New Drug Substances and Products Q1A (R2)
To improve the quality of the pharmaceutical products and to ensure that safe, effective and high quality medicines are developed the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has developed the ICH quality guideline ICH Q1A (R2). This guideline covers the Stability Testing of New Drug Substances and products and determines the stability data package which are sufficient for a registration application within the three regions of EC, Japan and the United States. In this Webinar we will follow the content of the guideline and we will emphasize the stability testing criteria which will have to be followed for a successful stability testing procedure according to the valid guideline. There will topics as forced degradation studies, long-term and intermediate testing as well as accelerate testing considered. Furthermore most important factors of climate chambers to be used for stability testing are pointed out.
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