Seeking guidance documents for Non FDA Regulated Process Validation - New Equipment

[mshell]

I am attempting to develop validation document for a new piece of production equipment. I have pulled the FDA guidance but we do not have to meet FDA requirements. Does anyone have any guidance documents for non FDA regulated companies?

Thanks,

mshell

 

[Al Rosen]

I am attempting to develop validation document for a new piece of production equipment. I have pulled the FDA guidance but we do not have to meet FDA requirements. Does anyone have any guidance documents for non FDA regulated companies?

Thanks,

mshell

The principles don't change. Why not use it as a guide?

 

[mshell]

That is what we are doing at this time. I just don't want to go overboard.

 

[Statistical Steven]

That is what we are doing at this time. I just don't want to go overboard.

Al has a point, just use the FDA guidelines as just that...a guideline.

It sounds like you are qualilfying a machine versus a process validation study. If you are just qualifying a machine, try approaching it as a capability study, and look if the machine is repeatable and reproducible.