CRED Getting the CMC Dossier Right 2024

28/08/2024

Drug Substance – Quality Attributes

Residual Solvents (ICH Q3c)

Control of solvents according to ICH Q3C is vital

Solvents divided in 4 classes:

• Class 1: Solvents to be avoided (Avoid / fully justify)

• Class 2: Solvents to be limited (Fully justify)

• Class 3: Solvents with low toxic potential (Favoured)

• Class 4: Solvents with no safety data (A challenge!)

Exposure limits determined using:

• Option 1 (Concentration - ppm) - Favoured option!

• Option 2 (Permitted Daily Exposure – PDE – mg/day)

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Mutagenic Impurities • ICH – S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use – S9(R1): Nonclinical Evaluation for Anticancer Pharmaceuticals. – M7 on Assessment and control of DNA reactive impurities Drug Substance – Quality Attributes

• ICH M7 holds primacy

Supersedes EMEA/FDA/Ph.Eur guidances

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