Contrôle bactériologique et fongique de quelques médicaments commercialisés en Algérie

Abstract

The presence of microorganisms in pharmaceutical products poses a risk to patient health. Microbiological quality control occupies a key position in the pharmaceutical industry, in order to guarantee the quality and safety of finished products. The present study focuses on the microbiological quality control of 08 medicaments of different galenic forms. These analyses focused mainly on the enumeration of total germs, yeast and molds and the search for specific germs (S.aureus, E.coli and Salmonella). The results obtained show that, Cortrimoxal®, Amoxicillin®, Cedroxal® and Calsidose® have a good microbiological quality and comply with the standards recommended by the European Pharmacopoeia. On the other hand, Lexinal®, Inphadium®, Novoformine® and Zecuf® show microbial growth of S.aureus, E. coli and a high yeast count (176 ×10^3 UFC/g). These results do not comply with the 78 microbiological requirements set out by the European Pharmacopoeia. This contamination can change the Product quality level, and thus affect patient safety by triggering a therapeutic error. For this reason, rigorous controls must be carried out in well-equipped and well-organized laboratories by qualified personnel during medicaments production and before its release to the market.