Chromatography Forum

validation of pharmaceutical product testing is set out in ICH and FDA guidelines...what about the other agencies?...such as UKMRHA, TGA, ICH, EMEA and IMB......are all these agencies following the ICH and FDA guidelines?....or does each agency has there own guidelines?

The whole point to ICH is harmonization of the various regulations worldwide.

The whole point to ICH is harmonization of the various regulations worldwide.

Indeed thats the idea.

Seamoro, generally speaking the ICH guidelines apply for those areas (mainly US, EU and Japan) who have accepted those guidelines. But as indicated ICH do not provide a full set of GMP regulations. Other countries may have accepted /follow ICH as per principle but really do not keep track on that in my daily work. Cananda do have a non voting observer chair in the steering commitee.

So for US market you have ICH, CFR for general GMP and specific guidelines, for EU ICH, the EU GMP and specific guidelines.......

Not sure if TGA=Australia actually have accepted ICH in replacement for their analytical validation guideline for example, still valid last time I checked, so unsure there.