White Paper

Steps To Improve Collection, Management And Analysis Of Microbiology Samples

Source: Azbil North America – Biovigilant Division

By Aric Meares

Those who work in microbiology laboratories are aware of just how complex and expensive in terms of time and human resources, the collection, management, reading and interpretation of the data generated by the numerous samplings to keep up with the regulations for the release of pharmaceuticals. Their efforts for some time now do not seem to be enough. Inspectors devote more attention to the activities of the microbiology laboratory and, increasingly, their requirements are reports, statistics, correlations between the data, with the paper-based system, there may be only partially fulfill or at least not within the time limited and urgent inspections. What is now practically imposed by the new international guidelines is to adapt to the new management of data, which must be constantly monitored. The methodology, now applied in the sector of pharmaceutical, does not allow this type of efficiency. Adapt is not an easy task. Need to facilitate and speed up the tests of the monitoring of contamination controlled environments, provide report lists for any inquiries necessary to ensure the correct application of the rules of Good Manufacturing Practices.

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Azbil North America – Biovigilant Division