Qualidade microbiológica de formulações farmacêuticas de uma farmácia magistral no município de João Pessoa-PB.

Abstract

In the manufacturing process of products handled pharmacies must meet the requirements in or der to maintain product quality . The Nation al Health Surveillance Agency (ANVISA) through Board Resolution (RDC ) 67, 8 October 2007 establishing that the Good Compounding Practices (BPM ) and quality control of products are required to maintain the integrity of the product and user protec tion . Non - sterile products are those in which admits the presence of microbial load , although limited in view of the characteristics of it s use. Through RDC No. 481/99 (ANVISA ) and the Brazilian Pharmacopoeia 5th edition the allowed values of non - pathog enic microorganisms and the absence of pathogenic microorganisms in co smetic and non - sterile products , respectively is d etermined . The objective of this study was to evaluate the microbiological quality of pharmaceutical products handled in a masterly phar macy in the city of João Pessoa - PB. Six samples , which were analyzed by the method of serial dilutions plated on surface suitable for both bacteria and for fungi , in triplic ate culture media were acquired . The petri dish es were incubated at 36°C/3days for bacteria and 25°C/7 days for fungi when colony forming uni ts were assessed. As a result, it was observed that there was no growth o f microorganisms in the samples , indicating that they are in accordance with the specifications required limits microbial and thus are suitable for human consumption. Based on these results it was found that the production process of pharmaceuticals are analyzed according to the criteria of the legislation , thus ensuring safety, quality and efficacy of products.