Module 3 Presentations

07/05/2024

Which data is required in the Dossier?

3.2.2.8. Stability of the finished medicinal product a) The types of studies conducted, protocols used, and the results of the studies shall be summarised; b) Detailed results of the stability studies, including information on the analytical procedures used to generate the data and validation of these procedures shall be presented in an appropriate format; in case of vaccines, information on cumulative stability shall be provided where appropriate; c) The post authorisation stability protocol and stability commitment shall be provided.

(Annex 1 to Directive 2001/83/EC amended)

The Organisation for Professionals in Regulatory Affairs

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Summary

• What is stability and stability testing? • What are the factors, which endanger the stability of pharmaceuticals? • What are climate parameters? • What are Climatic zones? • Which data is required in the Dossier?

The Organisation for Professionals in Regulatory Affairs

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