Microbiology is an imprecise science. Large standard deviations are inherent to microbiological methods and often do not reflect the precision of the technician or the precision of an instrument. Guidelines for the of validation alternate methods try to account for this imprecision, but often do not go far enough. Unfortunately, this can put the QC lab in the position of failing perfectly good alternate methods. One has to ask, would the compendial test pass the guidelines for validation? The fact is, compendial methods would fail at an unacceptably high rate if they were held to the same standards.
Listen to this presentation to learn about two particular aspects of validation: precision and accuracy. Data generated in our own lab and in QC labs from large pharmaceutical companies will be used as examplars.