Module 3 Presentations

14/05/2024

3.2.S.2.4 Control of Critical Steps and Intermediates  Critical quality attributes (CQAs) of DS could be: o Purity/potency o Impurity profile (including potentially genotoxic compounds, nitrosamines and metals residues) o Solvation or hydration o Residual solvents and/or water o Solid state form (polymorphism/desired polymorph/solvate)

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Ranges and Controls for Critical Steps

 Normal Operating Range (NOR): o Natural variations that occur without any change being made in set points o NOR is within the PAR but cannot be controlled  Control Range (CR): o Set point ± limits for target setting e.g. desired temperature ± X⁰C  Proven Acceptable Range (PAR): o Upper and lower limits of a parameter (e.g temperature, reaction time etc) that have been shown to have no detrimental effects on quality o State mid-point of PAR as fixed point in dossier

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