Module 9 2024

03/09/2024

Common Scenarios - Stability

Product is not stable ● Characterise and identify cause ● Re-formulate / review storage conditions

The Organisation for Professionals in Regulatory Affairs

39

Common Scenarios – Reference Standard

Reference standard levels low ● Establish and qualify new reference standard ● Cross over characterisation (ICH Q6b)

The Organisation for Professionals in Regulatory Affairs

40

20