Validation of Alternative Microbiology Methods for Product Testing Quantitative and Qualitative Assays

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Pharmaceutical Technology, Pharmaceutical Technology-04-02-2005, Volume 29, Issue 4

The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results.To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the pparent number in the sample.