Microbiology testing in pharmaceutical development and manufacture is used for environmental monitoring, sterility testing, and detection and identification of microorganisms and the applicable regulations for this work are Good Manufacturing Practices (GMP). Currently, data integrity is a major issue in the pharmaceutical industry and citations from the FDA arise due to failure to perform actual testing or falsification of data e.g. reporting failed tests as passes or modifying records. The reasons are often due to shortcomings of manual microbiological data testing methods. To address this issue, this collection of white papers covers:
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