Stability study with no planned subsequent inspection after initial test

[Former Member]

Hi

I am facing a situation where user takes samples after production of semi-finished good and store them as stability samples for the period of 12 month. And no predefined intervals / frequency for subsequent testing is scheduled, say after each month or each quarter.

But if a testing is required on demand, sample stored may be used for testing for the period of study.

I have created a strategy and defined only one package at the end of 12 month, though no planned testing take place.

Please tell me how should I use strategy and packages for stability planning in situation where stability samples are only tested when needed.

[former_member42743 · Accepted solution]

Why are these set up as stability samples? Why not just create the as reserve samples? I'm not sure I follow what benefit there is in having these set up as stability samples.

FF