CRED Getting the CMC Dossier Right 2024

28/08/2024

Drug Substance – Quality Attributes Elemental Impurities • Pre-2014 regulatory position

Metal catalysts: Pd, Pt, Rh, Ru, etc...

• Control of metal catalysts only.

• Current regulatory position - ICH Q3D

• Three classes of Elemental impurity

• See excellent ICH Q3D training package

Metal catalysts: Pd, Pt, Rh, Ru etc... AND Environmental impurities: As, Cd, Pb, Hg V, Ni, Co etc…

http://www.ich.org/products/guidelines/quality /article/quality-guidelines.html

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Elemental Impurities – USP 232/233 & ICH Q3D a) Move to risk based control strategies that consider all potential sources of metal impurities in drug products b) decrease in some permitted daily exposure (PDE) limits c) limits for some ‘new’ elements d) updated analytical technology Drug Substance – Quality Attributes

Manufacturing equipment *

Drug Substance

Metal Catalysts

Inorganic Reagents

Manufact. Equipment

Elemental impurities in drug Product

Elemental Impurities in DS

Primary Container Closure

Processing Aids

Organic Materials

Solvents

Water **

Container Closure System

Excipients

Water

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