stability study initial test

[Former Member]

Hi guys,

I need to understand, practically why do we make the initial test in the stability study, SAP says that it is made to be sure that the initial sample and the subsequent ones will meet my requirements, but what does this mean ?? i need small clarification please.

Thanks in advance

[former_member186399]

Hello

What happens if the initial test fail ? What is the point in doing the staibilty study when the initial sample itself is not ok.

But still you can continue the staiblity test. intial test is a part of the process

Hope this explains

Regards

Gajesh

[Former Member]

ya that's fine

thanks a lot Gajesh

[former_member186399]

Hello

Intial test is the first step in the process of stability studies. During the initial test you inspect the initial sample and record inspection results. based on these results you decide whether to continue the stability test or not . If you decide to continue the stability study based on the results of the initial test, you begin planning the extended series of stability tests

Regards

Gajesh

[Former Member]

Hi Gajesh

well i know what you have said, my point is: what is the relation between the initial test results' and the stability study, i mean what is the case that might stop me from completing the study

thanks for your concern

Regards