Análise crítica de três guias oficiais de validação de métodos analíticos em vigor no Brasil.

Introduction: From the XX century, with the emergence of pharmaceutical industries after the discovery of penicillin, accidents involving drugs boosted advances that culminated in the creation and adoption of good manufacturing practices (GMPs) in that field and, in parallel, with the principles and mandatory use of validations of processes and analytical methods. In general, the ICH validation guide is the most used in this area. However, improprieties and discrepancies in the definitions of validation characteristics contained in this guide and others have been reported. In Brazil there are three official guides in force at present (ANVISA, INMETRO and MAPA). Aim: To critically analyze the definitions of the validation characteristics contained in the official Brazilian validation guidelines and their agreement with the standard definitions. Methods: the definitions were selected from the specific literature and use them as standard definitions in the evaluation of official Brazilian guidelines. Results: It was found that the agreement of the three official Brazilian norms with the standard definitions for the validation characteristics was 37.5%, ANVISA; 50%, INMETRO and 62.5%, MAPA. Conclusions: It is essential to have clear and scientifically relevant definitions for the different validation characteristics and to use appropriate statistical methods for its evaluation. Harmonization between the different official standards would also be important to avoid discrepancies between the sectors regulated by the different bodies in the country. [ABSTRACT FROM AUTHOR]