Module 9 2024

03/09/2024

Why?

Example Changes

Typical reasons for changes

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Formulation

• Part of a CAPA for unexpected results

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Manufacturing facility

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• Current facility cannot support required scale for later stage clinical/commercial supply

Manufacturing process (scale, parameters, steps)

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• Technology transfer/scale related changes

Analytical methods

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Controls (in-process controls, intermediate and release specifications)

• Process optimisation related changes

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• Supplier change notification

Container closure

Availability

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•

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What do we do?

Change map

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• Highlight change and identify what other steps are affected

Risk assess

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• Assess potential impact of the change(s) to the product quality, safety and efficacy (FMEA: ICH Q9)

Comparability

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• Conduct analytical comparability (ICH Q5E) assessment to demonstrate that the product quality, efficacy and safety are unaffected

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