Module 9 2024

05/09/2024

Added Complexity of Variable Reference Product!

⚫ Batch-to-batch ⚫ Process changes

Test many batches over extended period!!!

The Organisation for Professionals in Regulatory Affairs

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Tiered Approach to Similarity Assessment

TIER 1 ATTRIBUTES

90% CI

- 1.5σ c

+ 1.5σ c

Equivalence approach

TIER 2 ATTRIBUTES

- 3σ c

+ 3σ c

Quality range approach

90% of batches

The Organisation for Professionals in Regulatory Affairs

30

15