Medical Device Stability Studies - Non-validated pilot production

I want to start a thread dealing with stability studies for M. Devices.
A common way is to do 3 lots but is it ok that the first lot comes from a non-validated pilot production as long as the items has been verified by measurement etc?

Ronen E

Problem Solver
Staff member
Super Moderator

Typically stability studies are part of the pilot production validation, so yes - it's normal that the test units come from a yet unvalidated line. However, in such a setting the pilot line and the production process are expected to be qualified first and controlled within the limits that the line is supposed to be validated under. If successful, subsequent production will have to be controlled within the same, established limits.

The main point is that stability is (hopefully) established for a given production setting and a given set of controlled parameters settings (accounting for all the rest, which is noise, too), which is maintained for routine production later. Otherwise it's just anecdotal.

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