IR Spectrum as In-House Library Spectrum

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

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.

Thanks.

2

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

3

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

4

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