Harold Alexis Prada-Ramirez

Laboratorio Coaspharma SAS, Bogotá, Colombia


  • Review Article   
    Review on Enforcement of Alternative Microbiological Methods in the Pharmaceutical Industry
    Author(s): 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 .. Read More»
    DOI: 10.31858/0975-8453.14.10.616-621

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