Module 3 2019

3.2.S.2.5 Process Validation ➢ In-process testing is not the answer to all control strategies ➢ CHMP/QWP/130/96, 3.2.S.2.5 states

Steps that are identified in 3.2.S.2.4 as critical for the quality of the active substance should be validated, eg o Mixing of multiple components o Control of temperature and pH are critical o Addition of significant structural elements o Final purification step ➢ PV data for chemical DS not normally included in dossier according to ICH Q11(7.1)

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