Author/Editor		Čerk-Petrič, T
Title		Zahteve Ameriške agencije za prehrano in zdravila (FDA) za delo v analitskih laboratorijih
Type		članek
Source		In: Glavič P, Brodnjak-Vončina D, editors. Zbornik referatov s posvetovanja Slovenski kemijski dnevi 2001: 1. del; 2001 sep 20-21; Maribor. Maribor: Univerza v Mariboru, Fakulteta za kemijo in kemijsko tehnologijo,
Publication year		2001
Volume		str. 53-6
Language		slo
Abstract		Pharrnaceutical products sold in the American market must be registered, what means the subinition of a doctimentation for FDA approval. Major part of the documentation are analytical data; which have to be acquired, in accordance with current FDA and ICH guidelines and FDA expectations. In this paper there are described some recommendations on the Qualification of Analytical Instruments (preparation and content of Validation Master Plan, Validation Protocol and Validation Report). Another important issue is validation of analytical procedures, which are used throughout drug development, manufacturing and release of drug substances and products. So, the reliability of their results is essential. We can assure such results with the validated analytical procedures, where we proof of its suitability for the intended purpose.
Descriptors		DRUG INDUSTRY CHEMISTRY, PHARMACEUTICAL DRUG APPROVAL LEGISLATION, DRUG UNITED STATES FOOD AND DRUG ADMINISTRATION REPRODUCIBILITY OF RESULTS