CRED Getting the CMC Dossier Right 2024

28/08/2024

ICH Universal and Product Specific Tests

The Organisation for Professionals in Regulatory Affairs

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ICH Guidance

• Q6A Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances • Q6B Specifications: Test procedures and acceptance criteria for biotechnological/ biological products

• Q3B(R2) Impurities in new drug products • Q3C(R9) Guideline for residual solvents • Q3D(R2) Guideline for elemental impurities • Q3E Impurity: Assessment and control of E&L for pharmaceutics and biologics – Jan 2027 • Q8(R2) Pharmaceutical development • M7(R2) Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk • Q2(R2) Validation of analytical procedures • Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management • Q14 Analytical procedure development

The Organisation for Professionals in Regulatory Affairs

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