USP Assay Titration Method (Validation/Verification)

[jayroseville58]

any guidelines pertaining to what test can we include on validation/verification of USP Assay Titration method? Thanks.

[Markus Laeubli, Metrohm]

Dear jayroseville58

You will need a qualified titration system (IQ/OQ/PQ). You need to show that your application is able to determine the component of interest precisely and accurately.
For a qualified system most important will be titer of the titrand as well as perfomance of the electrode (if used).

[jayroseville58]

Dear jayroseville58

You will need a qualified titration system (IQ/OQ/PQ). You need to show that your application is able to determine the component of interest precisely and accurately.
For a qualified system most important will be titer of the titrand as well as perfomance of the electrode (if used).

what if, we are doing the titration by the aid of burette and not by means of autotitrator? thanks.

[KM-USA]

what if, we are doing the titration by the aid of burette and not by means of autotitrator? thanks.

Well, that eliminates the equipment qualification part anyway.

You could compare your lab results to those obtained by supplier using USP procedure or to USP-purchased material. Someone, somewhere will need to make a call on how close is close enough, I haven't found anything official on that. Also, I haven't found guidance whether such titrations (or even standardizations of titrants, even purchased titrants) should be done in singleton, duplicate, triplicate. And then how close such replicates need to be.

Nothing with USP is straightforward, unfortunately. My best advice is just document what you do, so that you could demonstrate good faith in any FDA audit.

You are in compliance only when THAT FDA auditor who comes to your facility decides you are in compliance......and only then....everything else is just an educated guess....