Module 3 Presentations

14/05/2024

Can IPC Testing be Avoided?

 On the whole ‘no’ but Process Analytical Technology (PAT) may replace some traditional IPC testing if technology is available (eg spectroscopy for reaction end point monitoring)  PAT offers the potential to increase quality by o Improved process control by real time monitoring o Reduced testing of intermediates and maybe API  Debate by no means finalised so IPC testing will be with us for years to come

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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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