Finished Product Stability study to cover all Climatic Zones

(Helen Crowley) #1

Hi, will data from long term stability studies at both 25°C / 60 % RH and 30°C / 75 % RH together with data from accelerated study at 40°C / 75 % RH be sufficient to cover Climatic Zones I, II, III, IVa and IVb?

Thank-you

(Pushpendra) #2

Stability data must demonstrate stability of the medicinal product throughout
its intended shelf life under the climatic conditions prevalent in the target
countries. Merely applying the same requirements appropriate to other markets
could potentially lead to substandard products if stability studies are conducted
at the storage conditions for countries in Climatic Zone I/II when the products
are supplied in countries in Climatic Zones III and IV.

(Helen Crowley) #3

Thank-you for your response.
So even though 40°C / 75 % RH is the harshest stability condition for accelerated studies this alone is not sufficient to cover Climatic Zones III and IVa IVb - you would also expect to see long term studies at either 30°C / 35 % RH for Zone III and 30°C / 65 % RH for Zone IVa and 30°C / 75 % RH for Zone IVb?