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28/08/2024

3.2.S.3 Characterisation

• Elucidation of Structure: NCE – include potential for isomerism, polymorphism -Q6A. Biotech- include desired product and product-related substances- Q6B • Impurities: Discussion of impurities and information on their qualification (impurities will also be referred to in 3.2.S.4.1 through 3.2.S.4.5)

References to ICH guidelines as appropriate for drug-type: Q3A, Q3C, Q5C, Q6A and Q6B

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3.2.S.4. Control of Drug Substance

• Specification: Q6A, Q6B, the new genotoxic guideline ICH M7 and links to finished product ICH Q3D (elemental)

• Analytical Procedures: Q2A, Q6B

• Validation of Analytical Procedures : Q2A, Q2B, Q6B

• Batch Analyses: Q3A, Q3C, Q6A, Q6B

• Justification of Specification: Q3a, Q3C, Q6A, Q6B

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