Abstract

Harold Alexis Prada-Ramirez63384*

The use of alternative microbiological methods has been encouraged by the United States Pharmacopeia (USP) guidelines, since they offer several advantages over the reference methods in terms of specificity, sensibility, accuracy, precision, and adaptability to technology. Generally, these alternative microbiological methods are automated systems that are less labor-intensive, allowing online measurement registration, real-time microbial monitoring, ensuring data integrity, traceability of the whole analysis and producing automated quality reports with all the parameters required in the pharmaceutical industry, thus reducing routine manual data transcription, which risks user mistakes. Nonetheless, in order to implement these innovative alternative methods within the pharmaceutical sector, there is a need to successfully perform the validation of these methods. The main purpose of this review is to show that an alternative method’s performance on the whole is not inferior to that of the conventional plate-count method for the detection and quantification of yeasts and molds. Therefore, following USP chapters 1223 and 1225, a quantitative validation was carried out in order to highlight essential quantitative validation parameters, such as equivalence of results, operating range, linearity, precision, accuracy, robustness, ruggedness, specificity, limit of detection, and limit of quantification. Thus the alternative microbiological method was found to meet all the validation criteria needed to be considered to be a viable method for yeasts’ and molds’ quantification in a tested antacid oral suspension.