Module 3 Presentations

07/05/2024

How are Specifications set? • Considering Staged Risk:

Threshold Reporting Identification Qualification

Exploratory Dev

Full Dev

0.05% 0.10%

ICH ICH

Phases 1 and 2

Phase 3

DS 0.5%

DP 0.5%

ICH

Identified*

0.2% 0.2% Unidentified * Provided no structural alert (e.g. for GenTox) Impurities acceptance criteria >0.5% only if agreed qualified by Safety Sciences In early Phases: if study duration is sufficiently long, default to Full Development controls

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

9

ICH Threshold. Example

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

10