Module 3 2019

Stability of Drug Product…always lot of questions!

What supporting stability data can I use?

Do we need Zone IVa/b stability?

What shelf-life can I assign?

Which country(s) for registration?

Can I submit 6 months real-time data at MAA/NDA submission?

Is drug product stable in Zone IVa/b?

My Drug Product is moisture sensitive!

Do we need site specific stability?

Do we need to invest in specialised packaging?

Do I require in- use stability?

Can I choose a harsher condition for stability?

I have stability data at 25 ℃ /60% RH…what is my storage condition?

Is stability data required only on commercial batches

How many batches do I need for stability during submission?

My commercial formulation is different to the clinical formulation!!

The Organisation for Professionals in Regulatory Affairs