IR Spectrum as In-House Library Spectrum

Hey guys, i would like to ask about if there is any supporting guidelines or GMP document to discuss about the way we estabilish an IR spectrum as in-house library spectrum.

For example, i know that we must use a primary reference standard as source.
Then, how do we know if it is reliable at the moment we establish.


None. The only requirement is that software must be validated (21 CFR part 11 and GAMP5).

So can anyone suggest the common way to verify a library u just have established?

Scientifically. Use manufacturer’s common libraries (Nicolet…) and add on to them.