CRED Getting the CMC Dossier Right 2024

05/09/2024

QbD Good Scientific Development

• Identify critical quality attributes (CQA) of the product based on QTPP

• Identify critical process parameters (CPPs) that could impact CQAs

• Identify critical material attributes (CMAs) of raw materials / API that could impact CQAs

• Perform studies by varying CPP settings / CMAs and determine impact on CQA (Design Of Experiments reduces number of experiments without losing information)

• Calculate model of CPP/CMA setting on CQA or use outcome of DoE to set Design Space boundaries

• Verify model at commercial scale or validate process at target settings

• Real time in-process QC rather than finished product tests (e.g. NIR)

• More regulatory freedom as movement within ‘Design Space’ can be done without the need for submitting variations

The Organisation for Professionals in Regulatory Affairs

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Production, Scale Up and Validation

The Organisation for Professionals in Regulatory Affairs

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