CRED Getting the CMC Dossier Right 2024

28/08/2024

Europe: Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products (1)

EMEA/CHMP/QWP/49313/2005 Corr Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products

• Mean Delivered Dose - The amount of drug substance in one actuation should also be determined by calculating the mean of the delivered dose uniformity test results, with corrections as necessary to convert from “per dose” amounts to “per actuation” amounts. Limits of ± 15% of the label claim apply.

The Organisation for Professionals in Regulatory Affairs

41

Europe: Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products (2)

The Organisation for Professionals in Regulatory Affairs

42

21