Controle de qualidade microbiológico de produtos farmacêuticos não estéreis

Abstract

Quality control is part of Good Manufacturing Practices (GMP), that arerelevant and necessary for that pharmaceuticals are not released for sale or supply until their quality is considered satisfactory. The present study aims to conduct a literature review on the subject microbiological quality control of non-sterile pharmaceutical products, focusing on the pharmaceutical industry. Non-sterile products are those in which is admitted, conceptually, the presence of microbial load that, although limited, is defined by microbial standards described in official compendia and regulatory standards, including the limits on the presence of microorganisms in the product and, among these, pathogens absence.Thus, the following text emphasizes the importance of microbiological quality control of pharmaceuticals, identifies the main sources of microbial contamination in industrial production process and the main methods used for analysis and describes the microbial limits recommended by official compendia, whereas the microbiologicalquality control constitutes one of the essential attributes to these products safety, efficacy and acceptability.