CRED Getting the CMC Dossier Right 2024

28/08/2024

Analytical Procedures and Validation

The Organisation for Professionals in Regulatory Affairs

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Analytical Procedures and Validation

• Analytical methods vs. Analytical procedures •

Analytical procedure refers to the way of performing the analysis and is defined in ICH Q2 • Analytical method refers to the principles of the method used. • Clinical FPS • Analytical method (often a summary description is provided e.g. chromatographic conditions) • Suitability of methods confirmation, with list of validation parameters for Phase 2 & 3 • Commercial FPS

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Analytical procedure

• Full method validation in line with ICH Q2(R2)

• Reference to Pharmacopoeial methods acceptable in both clinical and commercial phase – validation of Pharmacopoeial methods is not required

The Organisation for Professionals in Regulatory Affairs

46

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