Quite often these days, internet forum discussions or message boards address the important question of whether method validation is necessary in various scenarios and contexts. Validation of analytical methods for the production of pharmaceutical agents responds to regulatory requirements as expressed by GMP rules (21CFR211.165 (e) in the US and Eudralex Vol. 4 in the EU) or other rules (OECD GLP, ISO 17025, ISO 12787 for cosmetics, etc.). These rules should respond scientifically to a key question posed by most people in pharmaceutical production: are the data I generate reliable?