Chromatography Forum

I have recently inherited responsibility for the reference standard program at my company. I feel the program we have in place is sound but, since this is my first time being in charge of such a program, I wanted to check if there were any official regulations or guidance documents discussing the structure of a reference standard program. No one here seems to have heard of anything published by the FDA, EDQM, USP, ICH, etc. regarding this.

I'm just now starting my search online but if someone here knows of an official reference - or knows that there definitively is nothing on this topic - please post here.

Thanks in advance.

Hi

Well nothing is a bit suprising but I grant them that it is not much written in those guidelines as I recall, however if you check §11 in ICH Q7a you will find some basic requirements.

Thanks Krickos, this was quite helpful.

Hi

Thanks for feedback, feel free to expand topic if necessary.

Refer to Ph. Eur. Chapter 5.12 (Reference Standards), USP Chapter 11 (Reference Standard) and UK Orange Guide PII.11.17 (Laboratory Controls) for general information.