Validation are the FDA and ICH the only standard guidelines

Off-topic conversations and chit-chat.

3 posts Page 1 of 1
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.
-- Tom Jupille
LC Resources / Separation Science Associates
tjupille@lcresources.com
+ 1 (925) 297-5374
tom jupille wrote:
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.
Izaak Kolthoff: “Theory guides, experiment decides.”
3 posts Page 1 of 1

Who is online

In total there is 1 user online :: 0 registered, 0 hidden and 1 guest (based on users active over the past 5 minutes)
Most users ever online was 1117 on Mon Jan 31, 2022 2:50 pm

Users browsing this forum: No registered users and 1 guest

Latest Blog Posts from Separation Science

Separation Science offers free learning from the experts covering methods, applications, webinars, eSeminars, videos, tutorials for users of liquid chromatography, gas chromatography, mass spectrometry, sample preparation and related analytical techniques.

Subscribe to our eNewsletter with daily, weekly or monthly updates: Food & Beverage, Environmental, (Bio)Pharmaceutical, Bioclinical, Liquid Chromatography, Gas Chromatography and Mass Spectrometry.

Liquid Chromatography

Gas Chromatography

Mass Spectrometry