CRED Getting the CMC Dossier Right 2024

28/08/2024

ICH Specific Tests: Oral Liquids and Powders for reconstitution as oral liquids (4)

• Rheological properties • For viscous solutions or suspensions, viscosity/specific gravity • Reconstitution time • For dry powder products which require reconstitution • Water content •

For oral products requiring reconstitution, a test and acceptance criterion for water content should be proposed when appropriate • Loss on drying is generally considered sufficient if the effect of absorbed moisture vs. water of hydration has been adequately characterized during the development of the product • In certain cases, specific procedure (e.g., Karl Fischer titration) needed.

The Organisation for Professionals in Regulatory Affairs

33

ICH Specific Tests: Parenteral (1)

• Uniformity of dosage units: • Mass • Content • Depending on strength and percentage content - pharmacopoeial procedure should be used • pH • If CQA • Sterility • At release; CCI can be justified during shelf-life • Endotoxins/Pyrogens • Endotoxins part of the specifications at release using a procedure such as the limulus amoebocyte lysate (LAL) test

Particulate matter •

•

Visible particulates and / or clarity of solution • Sub-visible particulates

The Organisation for Professionals in Regulatory Affairs

34

17