CRED Getting the CMC Dossier Right 2024

28/08/2024

ICH Specific Tests: Tablets, capsules, granules (2)

• Uniformity of dosage units • Mass • Content • Depends on strength and percentage content - pharmacopoeial procedure should be used • Water content • Loss on drying or specific method, e.g Karl Fisher, if appropriate • Microbial limits • Omission of testing is possible if components are tested before manufacture and the manufacturing process is known, through validation studies, not to carry a significant risk of microbial contamination or proliferation

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ICH Specific Tests: Oral Liquids and Powders for reconstitution as oral liquids (1)

Uniformity of dosage units

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Mass

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Content

• Depends on strength and percentage content - pharmacopoeial procedure should be used • pH • If CQA • Microbial limits: • Omission of testing is possible if components are tested before manufacture and the manufacturing process is known, through validation studies, not to carry a significant risk of microbial contamination or proliferation

Antimicrobial preservative • Acceptance criteria should ensure appropriate preservation during the shelf life

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The Organisation for Professionals in Regulatory Affairs

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