Module 9 2024

05/09/2024

CMC Requirements: Criticality Assessment Zarxio Example

Match

Tier 1

Semi quantitative and qualitative attributes cannot be Tier 1

Tier 2

Tier 3

The Organisation for Professionals in Regulatory Affairs

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CMC Requirements: Criticality Assessment

• 2/3 Indicator non granular attributes that directly impact safety/potency • e.g. bioactivity, receptor binding

These required to fall within +/- 1.5 SD for results from multiple reference product batches.

V High Tier 1

Quality range approach generally ±3SD based on multiple reference product batches.

• Non Tier 1 attributes that have at least some potential impact on safety/ potency

High Tier 2

• Non quantitative or heavily granular or attributes with low/no impact on potency PK/safety/immunog. e.g. fully active natural variants

Descriptive Graphical display

Low Tier 3

The Organisation for Professionals in Regulatory Affairs

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