Steps To Improve Collection, Management And Analysis Of Microbiology Samples

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.

To find a solution to this problem a few years ago, a project was started, which involved a software development company, a group of employees working in pharmaceutical companies, for the contribution of know-how in the field of microbiology and a external consultant for the implementation of GMP in the pharmaceutical industry and the requirements of 21 CFR part 11. The goal was to create a software system that would allow to:

• Improve the quality of the activities of the microbiology laboratory at any time and have the situation under control;
• Managing data in accordance with GAMP and 21 CFR part 11;
• Reduce dramatically the time management easier and faster operations relating to the checks of the monitoring of contamination controlled environments, providing report lists for any inquiries.

The system had to be structured to meet the needs of the microbiological laboratory, in particular had to manage data generated by the activities of the laboratory environments for Air, Water, Gases, compressed, Personnel, Materials and Products finished. In the formulation of User Requirements (URS) will put particular attention to certain fundamental characteristics of importance: Simple user interface and intuitive The application would be used by more professionals and with different levels of familiarity with computer systems, and all should be allowed to access the desired information in a clear and quick.

Video management company and the provision of seedlings of sampling points Before the creation of the system, whenever it was overrun their acceptance criteria, to inform the technical director, the WFD and the various members of the DCQ, had to be prepared a report with attached photocopy of a map area or local, with an arrow showing the sampling point indicted, indicating the measured value, the date and the time of sampling and acceptance limits. To eliminate this laborious way of proceeding and in order to allow managers concerned to immediately assess the situation, the software should allow you to send an email in which they were placed, by default, all the details.

Trend display of the values of the samples of a given period, starting from the selection of point from map of an area or a local.

This surely would have to get the trend quickly and above all have permission to perform correlations between sampling points neighboring although of different kinds. Highlighting the graph of Trend acceptance limits by colored lines, and display of the deviation linear regression line options, when you see a trend to go back to all the information related With a simple click of the mouse on any chart value, he should be able to view the page laboratory notebook (sampling plan) on the day and at the sampling point selected. This would allowed to have a complete view of all samples run in the same area and all the information concerning: the author of the drawings, the date and time, the production lots involved, organisms identified, the equipment used, the land used with their respective due dates etc. Automatic generation of periodic reports. A primary goal was to recover the time lost by staff, the manual preparation of dossiers periodic and annual trends in order to free resources for the activities in the field.

Deviation Management
He should be able to get a list of all deviations open, and a clinic should be all details, such as the affected batches, sampling etc. involved. After many years since the project began the software has finally become a reality with the name of BioTrends™ and is, in now used by many pharmaceutical companies. During the countless inspections taking place in the pharmaceutical sector, this software becomes an essential tool in order to show that the whole Department of Microbiology and throughout the plant are closely monitored. Thanks to suggestions from the users satisfied with its usefulness and effectiveness, BioTrends™ is in constant update. Integration with advanced systems such as handheld integrated barcode reader made BioTrends a must.