Proposal of sanitary lines of direction for evaluation of the shelf life of health assistance biocides

Abstract

There is no current law in Brazil with a scientifically based guide for performing stability studies for sanitary products. The goal of this work is to analyze the legislation for registering sanitary products of health assistance used in Brazil while comparing its study criteria with the ones of international legislation. The international legislation presented a more rigid criteria for (i) proposed shelf life quality and safety specification evaluation; (ii) label information and packing behavior evaluation; (iii) use of validated analysis methodology; and (iv) studies to simulate the product variations in the conditions of use when applicable (i.e. dilutions or activation for use). In order to regulate this procedure as part of the Agencia Nacional de Vigilância Sanitária - Brazil (ANVISA) routine for sanitary registry administrative process, a guide suitable for the reality of the brazilian productive sector is proposed as a result, after critically analyzing this legislation.