GLP or GCP for bioanalysis? [GxP / QC / QA]

posted by ElMaestro  – Denmark, 2019-01-20 14:54 (1914 d 14:28 ago) – Posting: # 19789
Views: 6,939

Dear nobody,

here I think you are going astray.

it is true the OECD GLP guidance was developed for nonclin./tox studies and this is stated in the preamble section of the document, but there is nothing, not one single paragraph anywhere in Eudralex or any other collection of legal or regulatory documents, which precludes regulators from applying the same standard (or another) in any field.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
22,986 posts in 4,823 threads, 1,658 registered users;
50 visitors (0 registered, 50 guests [including 6 identified bots]).
Forum time: 06:22 CEST (Europe/Vienna)

Art is “I”; science is “we”.    Claude Bernard

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5